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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100151
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):
Alkermes, Inc.

Brief 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

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period [ Time Frame: 4 Weeks ]
  2. Number of subjects reporting treatment-emergent adverse events (TEAEs) [ Time Frame: 6 Weeks ]
    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 :
  1. Change in rescue laxative use from pre-treatment to treatment period [ Time Frame: 4 Weeks ]
  2. Study drug dose prior to first SBM after randomization [ Time Frame: 4 weeks ]
  3. Scores to study-related questionnaires [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01100151

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.
Study Director: Bernard L. Silverman, MD Alkermes, Inc.

Responsible Party: Alkermes, Inc. Identifier: NCT01100151     History of Changes
Other Study ID Numbers: ALK37-003
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

Keywords provided by Alkermes, Inc.:
Opioid-induced constipation

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents