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ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Primary Purpose

OIC

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 OIC

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, 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

Sites / Locations

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

Placebo Comparator

Experimental

Arm Label

Placebo

ALKS 37

Arm Description

Capsules for oral administration

Capsules for oral administration

Outcomes

Primary Outcome Measures

Change from baseline in the weekly average of complete spontaneous bowel movements during treatment

Secondary Outcome Measures

Full Information

First Posted
August 15, 2011
Last Updated
July 31, 2012
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01418092
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 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 and efficacy of ALKS 37 when administered daily to adults with OIC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OIC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (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
Change from baseline in the weekly average of complete spontaneous bowel movements during treatment
Time Frame
Weeks 1 through 4 of treatment

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, 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
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 Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Alkermes Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Alkermes Investigational Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Alkermes Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Alkermes Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Alkermes Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Alkermes Investigational Site
City
Los Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Alkermes Investigational Site
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Alkermes Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Alkermes Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Alkermes Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

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