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WithdrawnNCT00858754Updated Nov 29, 2019

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

A Phase 4 interventional study of methylnaltrexone and placebo in Opioid-Induced Constipation, sponsored by Bausch Health Americas, Inc.. Withdrawn at 8 sites in 4 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-29.

Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Withdrawn \[This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Opioid-Induced Constipation

Keywords

  • opioid induced constipation
  • Cancer patients
  • methylnaltrexone
03

In context

Opioid-Induced Constipation

98 studies on the registry are indexed under Opioid-Induced Constipation; 6 are open to participants now.

Browse Opioid-Induced Constipation studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 213 studies on the registry; 9 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

First submitted before Bausch Health Americas, Inc. became part of Bausch Health Companies Inc..

Browse Bausch Health Americas, Inc. studies →All Bausch Health Companies Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Group 1 Active Drug

    Methylnaltrexone

    Drug: methylnaltrexone

  • Placebo comparator
    Group 2 Non-Active Drug

    Placebo

    Drug: placebo

Interventions

06

What researchers measure

Primary outcomes

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

    Time frame: 1 Day

Secondary outcomes

  1. 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

07

Study locations

8 sites
  • Pfizer Investigational Site
    Laguna Hills, California 92637, United States
  • Pfizer Investigational Site
    Lancaster, California 93534, United States
  • Pfizer Investigational Site
    Flat Rock, North Carolina 28731, United States
  • Pfizer Investigational Site
    Madison, Wisconsin 53792, United States
  • Pfizer Investigational Site
    Edmonton, Alberta T6G 1Z2, Canada
  • Pfizer Investigational Site
    Villejuif, 94804, France
  • Pfizer Investigational Site
    El Palmar, Murcia/Spain 30120, Spain
  • Pfizer Investigational Site
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00858754
Lead sponsor
Bausch Health Americas, Inc.
Collaborators
Progenics Pharmaceuticals, Inc.
First posted
Mar 10, 2009
Start date
Mar 2009
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Nov 29, 2019

Study contacts

Jeff Cohn
study director · Bausch Health Americas, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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