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Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

Primary Purpose

Opioid-Induced Constipation

Status
Withdrawn
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
methylnaltrexone
placebo
Sponsored by
Bausch Health Americas, 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, Cancer patients, methylnaltrexone

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is a man or woman aged 18 years or older.
  • Has a body weight >= 38 kg.
  • Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
  • Has a life expectancy of >= 6 months.
  • Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Is taking opioids for cancer-related pain, and not just as-needed doses.
  • Has a diagnosis of OIC as determined by the investigator.
  • Is willing to follow the protocol instructions on laxative use during the study.

Exclusion Criteria:

  • Has a history of chronic constipation before starting opioids.
  • Has renal disease receiving dialysis.
  • Has an ostomy for stools.
  • Is a pregnant or breastfeeding woman.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1 Active Drug

Group 2 Non-Active Drug

Arm Description

Methylnaltrexone

Placebo

Outcomes

Primary Outcome Measures

Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.

Secondary Outcome Measures

1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.

Full Information

First Posted
March 9, 2009
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00858754
Brief Title
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn [This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Progenics Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

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, Cancer patients, methylnaltrexone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Active Drug
Arm Type
Experimental
Arm Description
Methylnaltrexone
Arm Title
Group 2 Non-Active Drug
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
methylnaltrexone
Other Intervention Name(s)
MOA-728
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Inactive
Primary Outcome Measure Information:
Title
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is a man or woman aged 18 years or older. Has a body weight >= 38 kg. Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer). Has a life expectancy of >= 6 months. Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale. Is taking opioids for cancer-related pain, and not just as-needed doses. Has a diagnosis of OIC as determined by the investigator. Is willing to follow the protocol instructions on laxative use during the study. Exclusion Criteria: Has a history of chronic constipation before starting opioids. Has renal disease receiving dialysis. Has an ostomy for stools. Is a pregnant or breastfeeding woman.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Cohn
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
Pfizer Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Pfizer Investigational Site
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Villejuif Cedex
ZIP/Postal Code
94804
Country
France
Facility Name
Pfizer Investigational Site
City
El Palmar
State/Province
Murcia/Spain
ZIP/Postal Code
30120
Country
Spain
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3200K1-4006&StudyName=Study%20Evaluating%20Safety%20%26%20Efficacy%20of%20Subcutaneous%20Methylnaltrexone%20on%20Opioid-Induced%20Constipation%20in%20Cancer%20Subjects
Description
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Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

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