Clinical trial NCT01382797: ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-induced Constipation
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Alkermes Study Site
state: Arizona
city: Phoenix
country: United States
facility: Alkermes Study Site
state: Arizona
city: National City
country: United States
facility: Alkermes Study Site
state: California
city: Oceanside
country: United States
facility: Alkermes Study Site
state: California
city: Pasadena
country: United States
facility: Alkermes Study Site
state: California
city: Denver
country: United States
facility: Alkermes Study Site
state: Colorado
city: De Land
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Alkermes Study Site
state: Florida
city: St. Petersburg
country: United States
facility: Alkermes Study Site
state: Florida
city: Stockbridge
country: United States
facility: Alkermes Study Site
state: Georgia
city: Boise
country: United States
facility: Alkermes Study Site
state: Idaho
city: New Orleans
country: United States
facility: Alkermes Study Site
state: Louisiana
city: Kalamazoo
country: United States
facility: Alkermes Study Site
state: Michigan
city: Las Vegas
country: United States
facility: Alkermes Study Site
state: Nevada
city: Belvidere
country: United States
facility: Alkermes Study Site
state: New Jersey
city: Brooklyn
country: United States
facility: Alkermes Study Site
state: New York
city: Cincinnati
country: United States
facility: Alkermes Study Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Study Site
state: Oklahoma
city: Medford
country: United States
facility: Alkermes Study Site
state: Oregon
city: San Antonio
country: United States
facility: Alkermes Study Site
state: Texas
Study officials:
affiliation: Alkermes, Inc.
name: Richard Leigh-Pemberton, M.D.
role: STUDY_DIRECTOR
References: