ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)

Opioid-induced Constipation Clinical Trial

Official title:

A Phase 2 Study of the Effects of RDC-1036 Administered to Subjects With Opioid-induced Constipation During Treatment With Opioids for Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100151
• Other study ID #: ALK37-003
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2010
• Last updated: August 18, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• 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 assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration

Description:

Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 to 70 years of age

• Body mass index (BMI) of 19 to 35 kg/m2 at screening

• Receiving prescribed opioid medication for the management of chronic, non-cancer, pain

• Diagnosis of opioid-induced constipation (OIC)

• Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during 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) or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)

• Use of medical devices such as pacemakers, infusion pumps, or insulin pumps

• 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: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

Drug:
• RDC-1036 (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	Boise	Idaho
United States	Alkermes Investigational Site	Dayton	Ohio
United States	Alkermes Investigational Site	DeLand	Florida
United States	Alkermes Investigational Site	New Orleans	Louisiana
United States	Alkermes Investigative Site	New Smyrna Beach	Florida
United States	Alkermes Investigational Site	Pasadena	California
United States	Alkermes Investigational Site	Salt Lake City	Utah
United States	Alkermes Investigational Site	Sheffield	Alabama
United States	Alkermes Investigational Site	Walnut Creek	California
United States	Alkermes Investigational Site	Winston-Salem	North Carolina

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 in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period		4 Weeks	No
Primary	Number of subjects reporting treatment-emergent adverse events (TEAEs)	A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).	6 Weeks	No
Secondary	Change in rescue laxative use from pre-treatment to treatment period		4 Weeks	No
Secondary	Study drug dose prior to first SBM after randomization		4 weeks	No
Secondary	Scores to study-related questionnaires		6 weeks	No