ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
NCT ID: NCT01382797
Last Updated: 2012-06-13
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
157 participants
INTERVENTIONAL
2011-08-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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, 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 Study Site
Mesa, Arizona, United States
Alkermes Study Site
Phoenix, Arizona, United States
Alkermes Study Site
National City, California, United States
Alkermes Study Site
Oceanside, California, United States
Alkermes Study Site
Pasadena, California, United States
Alkermes Study Site
Denver, Colorado, United States
Alkermes Investigational Site
DeLand, Florida, United States
Alkermes Study Site
Ormond Beach, Florida, United States
Alkermes Study Site
St. Petersburg, Florida, United States
Alkermes Study Site
Stockbridge, Georgia, United States
Alkermes Study Site
Boise, Idaho, United States
Alkermes Study Site
New Orleans, Louisiana, United States
Alkermes Study Site
Kalamazoo, Michigan, United States
Alkermes Study Site
Las Vegas, Nevada, United States
Alkermes Study Site
Belvidere, New Jersey, United States
Alkermes Study Site
Brooklyn, New York, United States
Alkermes Study Site
Cincinnati, Ohio, United States
Alkermes Study Site
Oklahoma City, Oklahoma, United States
Alkermes Study Site
Medford, Oregon, United States
Alkermes Study Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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ALK37-005
Identifier Type: -
Identifier Source: org_study_id
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