search
Back to results

Study of Methylnaltrexone (MNTX) for the Relief of Constipation

Primary Purpose

Advance Illness Patients With OIC

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SC Methylnaltrexone
SC Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advance Illness Patients With OIC

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age and older
  • Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
  • Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
  • patient must sign ICF

Exclusion Criteria:

  • Women who are pregnant and/or nursing
  • Previous treatment with MNTX
  • Participation in any other studies involving investigational products within 30 days prior to screening

Sites / Locations

  • Progenics Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.
To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2006
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00402038
Brief Title
Study of Methylnaltrexone (MNTX) for the Relief of Constipation
Official Title
A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
Detailed Description
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Illness Patients With OIC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SC Methylnaltrexone
Intervention Description
Dose 1
Intervention Type
Drug
Intervention Name(s)
SC Placebo
Primary Outcome Measure Information:
Title
Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period.
Description
To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and older Negative pregnancy test (serum or urine) at screening for all women of childbearing potential Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month patient must sign ICF Exclusion Criteria: Women who are pregnant and/or nursing Previous treatment with MNTX Participation in any other studies involving investigational products within 30 days prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tage Ramakrishna, MD
Organizational Affiliation
Progenics Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Progenics Pharmaceuticals, Inc.
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33788162
Citation
Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31. Erratum In: Drugs Aging. 2021 Apr 23;:
Results Reference
derived
PubMed Identifier
31951150
Citation
Chamberlain BH, Rhiner M, Slatkin NE, Stambler N, Israel RJ. Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer. Pain Manag. 2020 Mar;10(2):73-84. doi: 10.2217/pmt-2019-0045. Epub 2020 Jan 17.
Results Reference
derived
PubMed Identifier
24815199
Citation
Nalamachu SR, Pergolizzi J, Taylor R Jr, Slatkin NE, Barrett AC, Yu J, Bortey E, Paterson C, Forbes WP. Efficacy and Tolerability of Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: A Responder Analysis of 2 Randomized, Placebo-Controlled Trials. Pain Pract. 2015 Jul;15(6):564-71. doi: 10.1111/papr.12218. Epub 2014 May 10.
Results Reference
derived
PubMed Identifier
21657861
Citation
Lipman AG, Karver S, Cooney GA, Stambler N, Israel RJ. Methylnaltrexone for opioid-induced constipation in patients with advanced illness: a 3-month open-label treatment extension study. J Pain Palliat Care Pharmacother. 2011;25(2):136-45. doi: 10.3109/15360288.2011.573531.
Results Reference
derived
PubMed Identifier
18509120
Citation
Thomas J, Karver S, Cooney GA, Chamberlain BH, Watt CK, Slatkin NE, Stambler N, Kremer AB, Israel RJ. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 May 29;358(22):2332-43. doi: 10.1056/NEJMoa0707377.
Results Reference
derived
Links:
URL
http://www.progenics.com
Description
Related Info

Learn more about this trial

Study of Methylnaltrexone (MNTX) for the Relief of Constipation

We'll reach out to this number within 24 hrs