Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-22 @ 8:08 AM
Study NCT ID:
NCT02187094
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2014-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.', 'timeFrame': '4 hrs post-GEBT meal', 'description': 'Gastric emptying time will be assessed using the oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT) administered following each treatment.'}], 'secondaryOutcomes': [{'measure': 'The percent dose excreted as 13-CO2 at specific post-meal time points for each treatment relative to placebo after single dose administration of study drug in each arm.', 'timeFrame': '90 and 120 min post-GEBT meal'}, {'measure': 'The time of maximal rate of 13-CO2 expiration for each treatment relative to placebo after single dose administration of study drug in each arm.', 'timeFrame': '4 hrs post-GEBT meal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.', 'detailedDescription': 'This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in diabetic subjects with gastroparesis. The length of study participation for a subject is up to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period, subjects will complete 4 overnight drug assessment visits (treatment arms) where they will receive a randomized single dose of study drug and the GEBT. Each overnight visit will be separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4 dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score \\>22)\n* Gastroparesis confirmed using the GEBT\n* Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%\n* Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT\n* Body Mass Index (BMI) ≤ 40\n* Willingness to remain in clinical research facility for the protocol-required days of treatment and study procedures\n* Willingness to use a double barrier method of birth control (except post-menopausal females)\n* Able to understand study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* History of abdominal surgery including gastric banding procedure\n* Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube\n* Persistent daily vomiting\n* A history of eating disorder\n* Recent history of poor control of diabetes\n* Acute severe gastroenteritis\n* Have implanted or use any type of gastric electric stimulator\n* Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs\n* Use of medications potentially influencing upper gastrointestinal motility or appetite\n* Allergies or intolerance to egg, wheat, milk, or algae\n* Pregnant or lactating females\n* Presence of a clinically significant medical condition at any time during the study\n* Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs\n* Participated in an investigational drug study within 30 days of screening'}, 'identificationModule': {'nctId': 'NCT02187094', 'briefTitle': 'Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Targacept Inc.'}, 'orgStudyIdInfo': {'id': 'TC-6499-12-CLP-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One capsule of placebo administered as a single dose.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2 mg TC-6499', 'description': 'One capsule of 2 mg TC-6499 administered as a single dose.', 'interventionNames': ['Drug: TC-6499']}, {'type': 'EXPERIMENTAL', 'label': '5 mg TC-6499', 'description': 'One capsule of 5 mg TC-6499 administered as a single dose.', 'interventionNames': ['Drug: TC-6499']}, {'type': 'EXPERIMENTAL', 'label': '10 mg TC-6499', 'description': 'One capsule of 10 mg TC-6499 administered as a single dose.', 'interventionNames': ['Drug: TC-6499']}], 'interventions': [{'name': 'TC-6499', 'type': 'DRUG', 'armGroupLabels': ['10 mg TC-6499', '2 mg TC-6499', '5 mg TC-6499']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Horizon Research Group, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Prefered Research Partners, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Ventura Clinical Trials', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research associates, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'ClinSearch, LLC', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Quality Medical Research', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84058', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Aspen Clinical Research, LLC', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Targacept Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}