Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT01418092
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2011-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'dispFirstSubmitDate': '2012-07-31', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2011-08-15', 'dispFirstSubmitQcDate': '2012-07-31', 'studyFirstSubmitQcDate': '2011-08-15', 'dispFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the weekly average of complete spontaneous bowel movements during treatment', 'timeFrame': 'Weeks 1 through 4 of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['OIC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are at least 18 years of age at time of consent\n* Have a body mass index (BMI)of 19 to 35 kg/m2 at screening\n* Are receiving prescribed opioid medication for the management of chronic, non-cancer pain\n* Meet the criteria of OIC\n* Agree to use an acceptable method of contraception for the duration of the study\n\nExclusion Criteria:\n\n* Pregnancy and/or currently breastfeeding\n* Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)\n* Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction\n* Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction\n* Use of naloxone, Subutex or Suboxone, Revia, Vivitrol, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study\n* Participation in a clinical trial of a pharmacological agent within 30 days before screening'}, 'identificationModule': {'nctId': 'NCT01418092', 'briefTitle': 'ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 2b Randomized, Double-blind, Placebo-controlled, 12-week Study to Evaluate the Safety and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation', 'orgStudyIdInfo': {'id': 'ALK37-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsules for oral administration', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ALKS 37', 'description': 'Capsules for oral administration', 'interventionNames': ['Drug: ALKS 37']}], 'interventions': [{'name': 'ALKS 37', 'type': 'DRUG', 'description': 'Capsules for oral administration', 'armGroupLabels': ['ALKS 37']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules for oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 40.02789, 'lon': -74.86905}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Richard Leigh-Pemberton, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}