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

Opioid-induced Constipation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382797
• Other study ID #: ALK37-005
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2011
• Last updated: June 12, 2012
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

Drug:
• ALKS 37
Capsules for oral administration
• Placebo
Capsules for oral administration

Locations

Country	Name	City	State
United States	Alkermes Study Site	Belvidere	New Jersey
United States	Alkermes Study Site	Boise	Idaho
United States	Alkermes Study Site	Brooklyn	New York
United States	Alkermes Study Site	Cincinnati	Ohio
United States	Alkermes Investigational Site	De Land	Florida
United States	Alkermes Study Site	Denver	Colorado
United States	Alkermes Study Site	Kalamazoo	Michigan
United States	Alkermes Study Site	Las Vegas	Nevada
United States	Alkermes Study Site	Medford	Oregon
United States	Alkermes Study Site	Mesa	Arizona
United States	Alkermes Study Site	National City	California
United States	Alkermes Study Site	New Orleans	Louisiana
United States	Alkermes Study Site	Oceanside	California
United States	Alkermes Study Site	Oklahoma City	Oklahoma
United States	Alkermes Study Site	Ormond Beach	Florida
United States	Alkermes Study Site	Pasadena	California
United States	Alkermes Study Site	Phoenix	Arizona
United States	Alkermes Study Site	San Antonio	Texas
United States	Alkermes Study Site	St. Petersburg	Florida
United States	Alkermes Study Site	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	4 weeks	No