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

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).

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Key information

Conditions

Opioid-induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alkermes Study Site, Mesa, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ALKS 37

Drug

Capsules for oral administration

Placebo

Drug

Capsules for oral administration

Primary outcomes

Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.

Time frame: 4 weeks

Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 27, 2011
Registry last updated: Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed