ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
NCT ID: NCT01100151
Last Updated: 2011-08-23
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
60 participants
INTERVENTIONAL
2010-04-30
2010-12-31
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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RDC-1036 (ALKS 37)
Capsules for oral administration
RDC-1036 (ALKS 37)
Capsules for oral administration
Placebo
Capsules for oral administration
Placebo
Capsules for oral administration
Interventions
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RDC-1036 (ALKS 37)
Capsules for oral administration
Placebo
Capsules for oral administration
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 19 to 35 kg/m2 at screening
* Receiving prescribed opioid medication for the management of chronic, non-cancer, pain
* Diagnosis of opioid-induced constipation (OIC)
* Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during 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) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)
* Use of medical devices such as pacemakers, infusion pumps, or insulin pumps
* 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
70 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bernard L. Silverman, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Sheffield, Alabama, United States
Alkermes Investigational Site
Anaheim, California, United States
Alkermes Investigational Site
Pasadena, California, United States
Alkermes Investigational Site
Walnut Creek, California, United States
Alkermes Investigational Site
DeLand, Florida, United States
Alkermes Investigative Site
New Smyrna Beach, Florida, United States
Alkermes Investigational Site
Boise, Idaho, United States
Alkermes Investigational Site
New Orleans, Louisiana, United States
Alkermes Investigational Site
Winston-Salem, North Carolina, United States
Alkermes Investigational Site
Dayton, Ohio, United States
Alkermes Investigational Site
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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ALK37-003
Identifier Type: -
Identifier Source: org_study_id
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