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

COMPLETEDPHASE2

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

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

NCT01100151•Alkermes, Inc.

View on ClinicalTrials.gov

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

Detailed 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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (11)

Alkermes Investigational Site

Sheffield, Alabama, United States

Alkermes Investigational Site

Anaheim, California, United States

Alkermes Investigational Site

Pasadena, California, United States

Alkermes Investigational Site

Walnut Creek, California, United States

Alkermes Investigational Site

DeLand, Florida, United States

Alkermes Investigative Site

New Smyrna Beach, Florida, United States

Alkermes Investigational Site

Boise, Idaho, United States

Alkermes Investigational Site

New Orleans, Louisiana, United States

Alkermes Investigational Site

Winston-Salem, North Carolina, United States

Alkermes Investigational Site

Dayton, Ohio, United States

Key Dates

Start Date

April 1, 2010

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

August 23, 2011

Enrollment

ESTIMATED participants

Conditions

Opioid-induced Constipation

Interventions

RDC-1036 (ALKS 37)

DRUG

Placebo

DRUG

A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation

NCT01333540

Opioid-induced Constipation (OIC)

View study

TERMINATEDPHASE3

Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

NCT01901328

Opioid-Induced Constipation

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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