ALK37-005: A Study 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:

NCT01382797

First received: June 24, 2011

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Purpose

The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).

Condition	Intervention	Phase
Opioid-induced Constipation	Drug: ALKS 37 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation

U.S. FDA Resources

Further study details as provided by Alkermes:

Primary Outcome Measures:

Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.

Enrollment:	157
Study Start Date:	August 2011
Study Completion Date:	April 2012
Primary Completion Date:	April 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, 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382797

Locations

United States, Arizona
Alkermes Study Site
Mesa, Arizona, United States, 85206
Alkermes Study Site
Phoenix, Arizona, United States, 85053
United States, California
Alkermes Study Site
National City, California, United States, 91950
Alkermes Study Site
Oceanside, California, United States, 92056
Alkermes Study Site
Pasadena, California, United States, 91105
United States, Colorado
Alkermes Study Site
Denver, Colorado, United States, 80211
United States, Florida
Alkermes Investigational Site
De Land, Florida, United States, 32724
Alkermes Study Site
Ormond Beach, Florida, United States, 32174
Alkermes Study Site
St. Petersburg, Florida, United States, 33709
United States, Georgia
Alkermes Study Site
Stockbridge, Georgia, United States, 30281
United States, Idaho
Alkermes Study Site
Boise, Idaho, United States, 83704
United States, Louisiana
Alkermes Study Site
New Orleans, Louisiana, United States, 70114
United States, Michigan
Alkermes Study Site
Kalamazoo, Michigan, United States, 49009
United States, Nevada
Alkermes Study Site
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Alkermes Study Site
Belvidere, New Jersey, United States, 07823
United States, New York
Alkermes Study Site
Brooklyn, New York, United States, 11218
United States, Ohio
Alkermes Study Site
Cincinnati, Ohio, United States, 45224
United States, Oklahoma
Alkermes Study Site
Oklahoma City, Oklahoma, United States, 73134
United States, Oregon
Alkermes Study Site
Medford, Oregon, United States, 97504
United States, Texas
Alkermes Study Site
San Antonio, Texas, United States, 78228

Sponsors and Collaborators

Alkermes

Investigators

Study Director:

Richard Leigh-Pemberton, M.D.

Alkermes

More Information

No publications provided

Responsible Party:	Alkermes
ClinicalTrials.gov Identifier:	NCT01382797 History of Changes
Other Study ID Numbers:	ALK37-005
Study First Received:	June 24, 2011
Last Updated:	June 12, 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 May 22, 2013

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