Trial record 8 of 50 for:
Alkermes
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
This study has been completed.
Sponsor:
Alkermes
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01418092
First received: August 15, 2011
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
| Condition | Intervention | Phase |
|---|---|---|
|
OIC |
Drug: ALKS 37 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Alkermes:
Primary Outcome Measures:
- Change from baseline in the weekly average of complete spontaneous bowel movements during treatment [ Time Frame: Weeks 1 through 4 of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 91 |
| Study Start Date: | September 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Capsules for oral administration
|
Drug: Placebo
Capsules for oral administration
|
|
Experimental: ALKS 37
Capsules for oral administration
|
Drug: ALKS 37
Capsules for oral administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Are at least 18 years of age at time of consent
- Have a body mass index (BMI)of 19 to 35 kg/m2 at screening
- Are receiving prescribed opioid medication for the management of chronic, non-cancer pain
- Meet the criteria of OIC
- Agree to use an acceptable method of contraception for the duration of the study
Exclusion Criteria:
- Pregnancy and/or currently breastfeeding
- Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
- Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
- 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
- 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
- Participation in a clinical trial of a pharmacological agent within 30 days before screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418092
Locations
| United States, California | |
| Alkermes Investigational Site | |
| Anaheim, California, United States, 92804 | |
| Alkermes Investigational Site | |
| Orange, California, United States, 92868 | |
| United States, Florida | |
| Alkermes Investigational Site | |
| Daytona Beach, Florida, United States, 32117 | |
| Alkermes Investigational Site | |
| Plantation, Florida, United States, 33317 | |
| United States, Georgia | |
| Alkermes Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| United States, Indiana | |
| Alkermes Investigational Site | |
| Indianapolis, Indiana, United States, 46250 | |
| United States, Nevada | |
| Alkermes Investigational Site | |
| Los Vegas, Nevada, United States, 89119 | |
| United States, New Jersey | |
| Alkermes Investigational Site | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, North Carolina | |
| Alkermes Investigational Site | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Pennsylvania | |
| Alkermes Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Alkermes Investigational Site | |
| Austin, Texas, United States, 78756 | |
| Alkermes Investigational Site | |
| Houston, Texas, United States, 77098 | |
| United States, Washington | |
| Alkermes Investigational Site | |
| Bellevue, Washington, United States, 98007 | |
Sponsors and Collaborators
Alkermes
Investigators
| Study Director: | Richard Leigh-Pemberton, M.D. | Alkermes |
More Information
No publications provided
| Responsible Party: | Alkermes |
| ClinicalTrials.gov Identifier: | NCT01418092 History of Changes |
| Other Study ID Numbers: | ALK37-007 |
| Study First Received: | August 15, 2011 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Analgesics, Opioid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 17, 2013