ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Phase 2

Completed

• Conditions: OIC
• Interventions: Drug: Placebo; Drug: ALKS 37

• Registration Number: NCT01418092
• Lead Sponsor: Alkermes, Inc.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Study Start: 2011-09
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Disposition First Submitted: 2012-07-31
• Disposition First Submitted QC: 2012-07-31
• Last Update Submitted: 2012-07-31
• Disposition First Posted: 2012-08-07
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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, Vivitrol, 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: SINGLE_GROUP

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
Change from baseline in the weekly average of complete spontaneous bowel movements during treatment	Weeks 1 through 4 of treatment

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Bellevue, Washington, United States