ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid-induced Constipation

In brief

The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).

Key facts

Study ID

NCT01382797

Run by

Alkermes, Inc.

People needed

157

Starts

2011-08-01

Expected to finish

2012-04-01

Last updated by the study team

2012-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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, 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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