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ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Primary Purpose

Opioid-induced Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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

Eligibility Criteria

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

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

Sites / Locations

  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Investigational Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site
  • Alkermes Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ALKS 37

Arm Description

Capsules for oral administration

Capsules for oral administration

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2011
Last Updated
June 12, 2012
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01382797
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-induced Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules for oral administration
Arm Title
ALKS 37
Arm Type
Experimental
Arm Description
Capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
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
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.
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Leigh-Pemberton, M.D.
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Study Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Alkermes Study Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Alkermes Study Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Alkermes Study Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alkermes Study Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Alkermes Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Alkermes Investigational Site
City
De Land
State/Province
Florida
ZIP/Postal Code
32724
Country
United States
Facility Name
Alkermes Study Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Alkermes Study Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Alkermes Study Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Alkermes Study Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Alkermes Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Alkermes Study Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Alkermes Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Alkermes Study Site
City
Belvidere
State/Province
New Jersey
ZIP/Postal Code
07823
Country
United States
Facility Name
Alkermes Study Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11218
Country
United States
Facility Name
Alkermes Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Alkermes Study Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Facility Name
Alkermes Study Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Alkermes Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States

12. IPD Sharing Statement

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ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

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