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ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)

Primary Purpose

Opioid-induced Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RDC-1036 (ALKS 37)
Placebo
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-induced Constipation focused on measuring Opioid-induced constipation, RDC-1036, ALKS 37

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigative Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RDC-1036 (ALKS 37)

Placebo

Arm Description

Capsules for oral administration

Capsules for oral administration

Outcomes

Primary Outcome Measures

Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
Number of subjects reporting treatment-emergent adverse events (TEAEs)
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).

Secondary Outcome Measures

Change in rescue laxative use from pre-treatment to treatment period
Study drug dose prior to first SBM after randomization
Scores to study-related questionnaires

Full Information

First Posted
April 7, 2010
Last Updated
August 18, 2011
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01100151
Brief Title
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

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-induced Constipation
Keywords
Opioid-induced constipation, RDC-1036, ALKS 37

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RDC-1036 (ALKS 37)
Arm Type
Experimental
Arm Description
Capsules for oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
RDC-1036 (ALKS 37)
Intervention Description
Capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules for oral administration
Primary Outcome Measure Information:
Title
Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
Time Frame
4 Weeks
Title
Number of subjects reporting treatment-emergent adverse events (TEAEs)
Description
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Change in rescue laxative use from pre-treatment to treatment period
Time Frame
4 Weeks
Title
Study drug dose prior to first SBM after randomization
Time Frame
4 weeks
Title
Scores to study-related questionnaires
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard L. Silverman, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Alkermes Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Alkermes Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Alkermes Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Alkermes Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32734
Country
United States
Facility Name
Alkermes Investigative Site
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Alkermes Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Alkermes Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Alkermes Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Alkermes Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Alkermes Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States

12. IPD Sharing Statement

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ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)

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