Clinical trial NCT01100151: ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-induced Constipation
Keywords: Opioid-induced constipation
RDC-1036
ALKS 37
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
timeFrame: 4 Weeks
measure: Number of subjects reporting treatment-emergent adverse events (TEAEs)
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change in rescue laxative use from pre-treatment to treatment period
timeFrame: 4 Weeks
measure: Study drug dose prior to first SBM after randomization
timeFrame: 4 weeks
measure: Scores to study-related questionnaires
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Alkermes Investigational Site
state: Alabama
city: Anaheim
country: United States
facility: Alkermes Investigational Site
state: California
city: Pasadena
country: United States
facility: Alkermes Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Alkermes Investigational Site
state: California
city: DeLand
country: United States
facility: Alkermes Investigational Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Alkermes Investigative Site
state: Florida
city: Boise
country: United States
facility: Alkermes Investigational Site
state: Idaho
city: New Orleans
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Winston-Salem
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Salt Lake City
country: United States
facility: Alkermes Investigational Site
state: Utah
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L. Silverman, MD
role: STUDY_DIRECTOR
References: