ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
NCT ID: NCT01418092
Last Updated: 2012-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2011-09-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Capsules for oral administration
Placebo
Capsules for oral administration
ALKS 37
Capsules for oral administration
ALKS 37
Capsules for oral administration
Interventions
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ALKS 37
Capsules for oral administration
Placebo
Capsules for oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Leigh-Pemberton, M.D.
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Anaheim, California, United States
Alkermes Investigational Site
Orange, California, United States
Alkermes Investigational Site
Daytona Beach, Florida, United States
Alkermes Investigational Site
Plantation, Florida, United States
Alkermes Investigational Site
Marietta, Georgia, United States
Alkermes Investigational Site
Indianapolis, Indiana, United States
Alkermes Investigational Site
Las Vegas, Nevada, United States
Alkermes Investigational Site
Willingboro, New Jersey, United States
Alkermes Investigational Site
Raleigh, North Carolina, United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
Houston, Texas, United States
Alkermes Investigational Site
Bellevue, Washington, United States
Countries
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Other Identifiers
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ALK37-007
Identifier Type: -
Identifier Source: org_study_id