ALK37-003: A Study of RDC-1036 (ALKS 37) 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 assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration

Key facts

Study ID

NCT01100151

Run by

Alkermes, Inc.

People needed

60

Starts

2010-04-01

Expected to finish

2010-12-01

Last updated by the study team

2011-08-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 70 years of age
• 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.

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) 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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