Clinical trial NCT01418092: ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: OIC
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-16
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with 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, 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

Primary outcomes:
measure: Change from baseline in the weekly average of complete spontaneous bowel movements during treatment
timeFrame: Weeks 1 through 4 of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: Daytona Beach
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Plantation
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Marietta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Los Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Willingboro
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Raleigh
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
Study officials:
affiliation: Alkermes, Inc.
name: Richard Leigh-Pemberton, M.D.
role: STUDY_DIRECTOR
References: