Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-14 @ 1:05 AM
Study NCT ID:
NCT01983306
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2013-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614048', 'term': 'dolcanatide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2019-05-23', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2013-10-29', 'dispFirstSubmitQcDate': '2019-05-30', 'studyFirstSubmitQcDate': '2013-11-06', 'dispFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To evaluate stool consistency over the 4-week Treatment Period', 'timeFrame': '4 weeks', 'description': 'Compare SP-333 (1, 3 \\& 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment.'}, {'measure': 'To evaluate constipation-related symptoms over the 4-week Treatment Period', 'timeFrame': '4 weeks', 'description': 'Compare SP-333 (1, 3 \\& 6 mg) with placebo in rates of change from baseline in constipation-related symptoms over the 4 weeks of treatment.'}, {'measure': 'To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period.', 'timeFrame': '4 weeks', 'description': 'Compare SP-333 (1, 3 \\& 6 mg) with placebo in rates of change from baseline for bowel movement frequency responder rates \\[Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)\\] over the 4 weeks of treatment.'}], 'primaryOutcomes': [{'measure': 'Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period', 'timeFrame': '4 Weeks', 'description': 'Compare SP-333 (1, 3 \\& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period'}], 'secondaryOutcomes': [{'measure': 'To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC', 'timeFrame': '4 weeks', 'description': 'Compare the safety and tolerability of SP-333 (1, 3 \\& 6 mg) with placebo as measured by rates of adverse events, clinical laboratory abnormalities and significant changes in vital signs and ECGs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Constipation', 'Opioid', 'GC C Agonist', 'Pain'], 'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening\n* Must have active OIC at screening\n* Active OIC must be confirmed during baseline screening bowel habit and symptom diary\n* Must be on stable diet\n\nExclusion Criteria:\n\n* Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)\n* Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)\n* Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years\n* Unstable thyroid disease'}, 'identificationModule': {'nctId': 'NCT01983306', 'acronym': 'OIC', 'briefTitle': 'Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy', 'orgStudyIdInfo': {'id': 'SP333201-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SP-333 1 mg', 'description': '1 mg SP-333 orally once daily for 4-week Treatment Period', 'interventionNames': ['Drug: SP-333 1 mg']}, {'type': 'EXPERIMENTAL', 'label': 'SP-333 3 mg', 'description': '3 mg SP-333 orally once daily for 4-week Treatment Period', 'interventionNames': ['Drug: SP-333 3 mg']}, {'type': 'EXPERIMENTAL', 'label': 'SP-333 6 mg', 'description': '6 mg SP-333 orally once daily for 4-week Treatment Period', 'interventionNames': ['Drug: SP-333 6 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo orally once daily for 4-week Treatment Period', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SP-333 1 mg', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['SP-333 1 mg']}, {'name': 'SP-333 3 mg', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['SP-333 3 mg']}, {'name': 'SP-333 6 mg', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['SP-333 6 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '95831', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 38.58157, 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{'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 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'South Carolina', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 33.49182, 'lon': -80.85565}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '75218', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Synergy Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Renata Tenenbaum', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Synergy Pharmaceuticals Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}