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

OIC Clinical Trial

Official title:

A Phase 2b Randomized, Double-blind, Placebo-controlled, 12-week Study to Evaluate the Safety and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418092
• Other study ID #: ALK37-007
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2011
• Last updated: July 31, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: July 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 and efficacy of ALKS 37 when administered daily to adults with OIC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2012
• Est. primary completion date: June 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, 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

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

Related Conditions & MeSH terms

• Constipation
• OIC

Intervention

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

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Anaheim	California
United States	Alkermes Investigational Site	Austin	Texas
United States	Alkermes Investigational Site	Bellevue	Washington
United States	Alkermes Investigational Site	Daytona Beach	Florida
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Indianapolis	Indiana
United States	Alkermes Investigational Site	Los Vegas	Nevada
United States	Alkermes Investigational Site	Marietta	Georgia
United States	Alkermes Investigational Site	Orange	California
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	Plantation	Florida
United States	Alkermes Investigational Site	Raleigh	North Carolina
United States	Alkermes Investigational Site	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the weekly average of complete spontaneous bowel movements during treatment		Weeks 1 through 4 of treatment	No