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

Phase 2

Completed

• Conditions: Opioid-induced Constipation
• Interventions: Drug: Placebo; Drug: ALKS 37

• Registration Number: NCT01382797
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2011-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Disposition First Submitted: 2012-05-07
• Status Verified: 2012-06
• Disposition First Submitted QC: 2012-06-01
• Disposition First Posted: 2012-06-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsules for oral administration
ALKS 37	ALKS 37	Capsules for oral administration

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (2)

Alkermes Study Site; 🇺🇸 San Antonio, Texas, United States

Alkermes Investigational Site; 🇺🇸 De Land, Florida, United States