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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT01418092
First received: August 15, 2011
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.


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

Resource links provided by NLM:


Further study details as provided by Alkermes:

Primary Outcome Measures:
  • Change from baseline in the weekly average of complete spontaneous bowel movements during treatment [ Time Frame: Weeks 1 through 4 of treatment ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Capsules for oral administration
Drug: Placebo
Capsules for oral administration
Experimental: ALKS 37
Capsules for oral administration
Drug: ALKS 37
Capsules for oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01418092

Locations
United States, California
Alkermes Investigational Site
Anaheim, California, United States, 92804
Alkermes Investigational Site
Orange, California, United States, 92868
United States, Florida
Alkermes Investigational Site
Daytona Beach, Florida, United States, 32117
Alkermes Investigational Site
Plantation, Florida, United States, 33317
United States, Georgia
Alkermes Investigational Site
Marietta, Georgia, United States, 30060
United States, Indiana
Alkermes Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Nevada
Alkermes Investigational Site
Los Vegas, Nevada, United States, 89119
United States, New Jersey
Alkermes Investigational Site
Willingboro, New Jersey, United States, 08046
United States, North Carolina
Alkermes Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Alkermes Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Alkermes Investigational Site
Austin, Texas, United States, 78756
Alkermes Investigational Site
Houston, Texas, United States, 77098
United States, Washington
Alkermes Investigational Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Alkermes
Investigators
Study Director: Richard Leigh-Pemberton, M.D. Alkermes
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT01418092     History of Changes
Other Study ID Numbers: ALK37-007
Study First Received: August 15, 2011
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014