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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01100151
First received: April 7, 2010
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Opioid-induced Constipation
Drug: RDC-1036 (ALKS 37)
Drug: Placebo
Phase 2

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Number of subjects reporting treatment-emergent adverse events (TEAEs) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change in rescue laxative use from pre-treatment to treatment period [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Study drug dose prior to first SBM after randomization [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Scores to study-related questionnaires [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RDC-1036 (ALKS 37)
Capsules for oral administration
Drug: RDC-1036 (ALKS 37)
Capsules for oral administration
Placebo Comparator: Placebo
Capsules for oral administration
Drug: Placebo
Capsules for oral 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100151

Locations
United States, Alabama
Alkermes Investigational Site
Sheffield, Alabama, United States, 35660
United States, California
Alkermes Investigational Site
Anaheim, California, United States, 92801
Alkermes Investigational Site
Pasadena, California, United States, 91105
Alkermes Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
Alkermes Investigational Site
DeLand, Florida, United States, 32734
Alkermes Investigative Site
New Smyrna Beach, Florida, United States, 32168
United States, Idaho
Alkermes Investigational Site
Boise, Idaho, United States, 83704
United States, Louisiana
Alkermes Investigational Site
New Orleans, Louisiana, United States, 70114
United States, North Carolina
Alkermes Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Alkermes Investigational Site
Dayton, Ohio, United States, 45432
United States, Utah
Alkermes Investigational Site
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Bernard L. Silverman, MD Alkermes, Inc.
  More Information

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01100151     History of Changes
Other Study ID Numbers: ALK37-003
Study First Received: April 7, 2010
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes, Inc.:
Opioid-induced constipation
RDC-1036
ALKS 37

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014