Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
Study NCT ID:
NCT00573261
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2007-12-12
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'weijiang@duke.edu', 'phone': '919-668-0762', 'title': 'Dr. Wei Jiang', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study has a high dropout, which might have reduced the power of the analysis. One of the major reasons that many patients were not able to participate was an inability to commit to the relatively intense and frequent assessments.'}}, 'adverseEventsModule': {'timeFrame': 'Participants were contacted by phone starting at the end of week 1 for potential adverse effects and titration of the study drug throughout 4-week treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pregabalin', 'description': 'Pregabalin medication\n\nPregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.', 'otherNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Physician defined'}, {'term': 'Swelling of the lower extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Physician defined'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin'}], 'classes': [{'title': 'Systolic Blood Pressure (mm Hg)', 'categories': [{'measurements': [{'value': '-7.63', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '-8.98', 'spread': '17.61', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure (mm Hg)', 'categories': [{'measurements': [{'value': '-4.41', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '-4.93', 'spread': '8.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.'}, {'type': 'SECONDARY', 'title': 'To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin'}], 'classes': [{'title': 'Visual analog pain rating', 'categories': [{'measurements': [{'value': '-21.29', 'spread': '35.62', 'groupId': 'OG000'}, {'value': '-43.27', 'spread': '32.03', 'groupId': 'OG001'}]}]}, {'title': 'Brief pain inventory - Total Pain', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '9.01', 'groupId': 'OG000'}, {'value': '-9.13', 'spread': '9.63', 'groupId': 'OG001'}]}]}, {'title': 'Brief pain inventory - Most Pain', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '3.46', 'groupId': 'OG001'}]}]}, {'title': 'Brief pain inventory - Least Pain', 'categories': [{'measurements': [{'value': '-0.071', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'Brief pain inventory - Average Pain', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-2.87', 'spread': '3.04', 'groupId': 'OG001'}]}]}, {'title': 'Brief pain inventory - Now pain', 'categories': [{'measurements': [{'value': '0.43', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Pain interference', 'categories': [{'measurements': [{'value': '-1.43', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '-13.93', 'spread': '10.35', 'groupId': 'OG001'}]}]}, {'title': 'Affective interference', 'categories': [{'measurements': [{'value': '-0.071', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '-5.27', 'spread': '5.71', 'groupId': 'OG001'}]}]}, {'title': 'Activity Interference', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '-8.67', 'spread': '7.03', 'groupId': 'OG001'}]}]}, {'title': 'Neuropathy pain scale (total)', 'categories': [{'measurements': [{'value': '-10.31', 'spread': '11.15', 'groupId': 'OG000'}, {'value': '-27.33', 'spread': '22.95', 'groupId': 'OG001'}]}]}, {'title': 'Cold pain', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': 'Sharp pain', 'categories': [{'measurements': [{'value': '-0.92', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '4.16', 'groupId': 'OG001'}]}]}, {'title': 'Deep pain', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '-3.00', 'spread': '3.51', 'groupId': 'OG001'}]}]}, {'title': 'Dull pain', 'categories': [{'measurements': [{'value': '0', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': 'Hot pain', 'categories': [{'measurements': [{'value': '-1.77', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Intense pain', 'categories': [{'measurements': [{'value': '-1.38', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': 'Itchy pain', 'categories': [{'measurements': [{'value': '0', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-4.07', 'spread': '3.92', 'groupId': 'OG001'}]}]}, {'title': 'Sensitive pain', 'categories': [{'measurements': [{'value': '-2.31', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'Surface pain', 'categories': [{'measurements': [{'value': '-1.46', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-3.20', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': 'Unpleasant pain', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '3.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and end of 4 week intervention', 'description': 'Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and their 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.'}, {'type': 'PRIMARY', 'title': 'Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.94', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '-3.49', 'spread': '5.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram.', 'unitOfMeasure': 'Beats Per Minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.'}, {'type': 'PRIMARY', 'title': 'Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin'}], 'classes': [{'title': 'Total Power', 'categories': [{'measurements': [{'value': '45.29', 'spread': '418.09', 'groupId': 'OG000'}, {'value': '-140.99', 'spread': '629.81', 'groupId': 'OG001'}]}]}, {'title': 'Low Frequency', 'categories': [{'measurements': [{'value': '32.41', 'spread': '229.51', 'groupId': 'OG000'}, {'value': '-67.06', 'spread': '252.06', 'groupId': 'OG001'}]}]}, {'title': 'High Frequency', 'categories': [{'measurements': [{'value': '-12.19', 'spread': '79.91', 'groupId': 'OG000'}, {'value': '-41.37', 'spread': '175.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz).', 'unitOfMeasure': 'Hertz (Hz)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.'}, {'type': 'PRIMARY', 'title': 'Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin\n\nPregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}], 'classes': [{'title': 'Low frequency/High frequency', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-1.30', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Normalized low frequency', 'categories': [{'measurements': [{'value': '0.0066', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '-0.049', 'spread': '0.092', 'groupId': 'OG001'}]}]}, {'title': 'Normalized high frequency', 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.066', 'groupId': 'OG000'}, {'value': '0.039', 'spread': '0.094', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/\\[total power-VLF\\]) and normalized HF (normalized HF=HF/\\[total power-VLF\\]).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin'}], 'classes': [{'title': 'ANN', 'categories': [{'measurements': [{'value': '21.47', 'spread': '84.56', 'groupId': 'OG000'}, {'value': '65.44', 'spread': '108.95', 'groupId': 'OG001'}]}]}, {'title': 'SDNN', 'categories': [{'measurements': [{'value': '3.42', 'spread': '8.83', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '20.03', 'groupId': 'OG001'}]}]}, {'title': 'SDANN', 'categories': [{'measurements': [{'value': '0.68', 'spread': '7.67', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '12.16', 'groupId': 'OG001'}]}]}, {'title': 'RMSSD', 'categories': [{'measurements': [{'value': '0.58', 'spread': '12.94', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '8.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN).', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.'}, {'type': 'PRIMARY', 'title': 'Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin\n\nPregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.97', 'spread': '92.66', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '41.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).', 'unitOfMeasure': 'Intervals more than 50 ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin\n\nPregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.011', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '0.0015', 'spread': '0.051', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin\n\nPregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}], 'classes': [{'title': 'State Anxiety', 'categories': [{'measurements': [{'value': '0.57', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '3.28', 'groupId': 'OG001'}]}]}, {'title': 'Trait Anxiety', 'categories': [{'measurements': [{'value': '1', 'spread': '6.16', 'groupId': 'OG000'}, {'value': '-3.67', 'spread': '5.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin'}], 'classes': [{'title': 'Disability scale - Global functioning score', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '-7.73', 'spread': '7.70', 'groupId': 'OG001'}]}]}, {'title': 'Disability scale - Work/school disability', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-2.93', 'spread': '3.26', 'groupId': 'OG001'}]}]}, {'title': 'Disability scale - Social disability', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Disability scale - Family disability', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '3.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}, {'id': 'FG001', 'title': 'Pregabalin', 'description': 'Pregabalin medication\n\nPregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the outpatient endocrine clinics of a tertiary academic center and locally via advertisement between March 3, 2006 and April 1, 2008.', 'preAssignmentDetails': 'There were 4 subjects who provided study consent but did not complete the baseline assessment because of unwillingness to wear the LifeShirt monitor (n=2 in placebo arm) and inability of keeping baseline assessment appointment due to job reassignment (n=2 in pregabalin arm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin', 'description': 'Pregabalin medication\n\nPregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.1', 'spread': '14.36', 'groupId': 'BG000'}, {'value': '59.65', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2007-12-12', 'resultsFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2007-12-12', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-15', 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'timeFrame': 'baseline and at end of a 4-week intervention'}, {'measure': 'Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram.'}, {'measure': 'Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz).'}, {'measure': 'Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/\\[total power-VLF\\]) and normalized HF (normalized HF=HF/\\[total power-VLF\\]).'}, {'measure': 'Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN).'}, {'measure': 'Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).'}], 'secondaryOutcomes': [{'measure': 'To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.', 'timeFrame': 'baseline and end of 4 week intervention', 'description': 'Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain.'}, {'measure': 'To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety).'}, {'measure': 'To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms)'}, {'measure': 'To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.', 'timeFrame': 'baseline and at end of a 4-week intervention', 'description': 'The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic neuropathy', 'Pregabalin', 'Lyrica'], 'conditions': ['Diabetic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '21346609', 'type': 'RESULT', 'citation': 'Jiang W, Ladd S, Martsberger C, Feinglos M, Spratt SE, Kuchibhatla M, Green J, Krishnan R. Effects of pregabalin on heart rate variability in patients with painful diabetic neuropathy. J Clin Psychopharmacol. 2011 Apr;31(2):207-13. doi: 10.1097/JCP.0b013e31820f4f57.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.', 'detailedDescription': 'This study is designed to primarily examine how pregabalin affects the autonomic nerve or sympathetic-parasympathetic regulation in patients with diabetic neuropathy and its relationship to neuropathic pain. The goals of this study include (1) assessing the change of parameters of autonomic nerve function such as heart rate variability (HRV), respiratory sinus arrhythmia (RSA), minute ventilation, and changes in objective sleep parameters measured by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo; (2) assessing the symptom change of neuropathic pain upon treatment of pregabalin in comparison to placebo; (3) assessing the change of anxiety symptoms upon treatment of pregabalin in comparison to placebo; (4) assessing the change of depressive symptoms upon treatment of pregabalin in comparison to placebo; (5) assessing the relationship of autonomic nerve function with neuropathic pain at baseline prior to treatment and the correspondences to the study drug; (6) assessing the relationship of autonomic nerve function with anxiety and depressive symptoms at baseline prior to treatment and their correspondences to the study drug; (7) identifying sensitive and reliable parameters of autonomic nerve regulation as predictor(s) of the severity and improvement of neuropathic pain and/or anxiety; and (8) to assess the change in objective sleep parameters (EEG/EOG) by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients aged 18 years or older\n* Meet criteria for diagnosis of diabetic neuropathy\n* Average daily pain scores greater than or equal to 4 by Visual Analog Scale\n* Ability to give informed consent\n* No pregnancy\n\nExclusion Criteria:\n\n* Patients with clinically significant psychiatric disorders requiring vigorous interventions, i.e., moderate to severe depressive disorder, psychotic disorders, PTSD, obsessive compulsive disorder, panic disorder, substance abuse, or personality disorders, or active suicidal/homicidal ideations, or past history of active suicidal ideation and/or attempts\n* Patients on gabapentin which cannot be discontinued, meaning a dose greater than 1200mg. If a patient is on a dose of gabapentin that is less than 1200mg and he or she is willing to stop taking the medication, he or she can participate in the study. These patients must take the last dose of gabapentin the night before starting the study.\n* Patients being non-compliant with diabetic control\n* Inability to wear the LifeShirt\n* Unable to participate or answer questions using a personal digital assistant input device'}, 'identificationModule': {'nctId': 'NCT00573261', 'acronym': 'Pregabalin', 'briefTitle': 'A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single Center Study Designed to Assess the Effects of Pregabalin on Change in Patients With Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'Pro00009557'}, 'secondaryIdInfos': [{'id': '2005-0003', 'type': 'OTHER', 'domain': 'Pfizer'}, {'id': '7511-05-8', 'type': 'OTHER', 'domain': 'Duke legacy protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregabalin', 'description': 'Pregabalin medication', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Wei Jiang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}