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A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

Primary Purpose

Advanced Illness Patients With Opioid Induced Constipation

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

SC Methylnaltrexone

SC Placebo

SC Methylnaltrexone

About this trial

This is an interventional treatment trial for Advanced Illness Patients With Opioid Induced Constipation

Eligibility Criteria

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

Inclusion Criteria:

Advanced medical illness with a life expectancy of 1 to 6 months
No clinically significant laxation within 48 hours prior to the first dose of study drug
On stable opioid and laxative regimen for a least 3 days prior to treatment
Age greater than 18years
Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria:

Females who are pregnant or nursing.
Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
Any disease process suggestive of gastrointestinal obstruction
Fecal ostomy.

Sites / Locations

Progenics Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm 1

Arm 3

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of SC MNTX compared with placebo in inducing laxation

The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.

Secondary Outcome Measures

Full Information

NCT ID

NCT00401362

First Posted

November 16, 2006

Last Updated

November 21, 2019

Sponsor

Bausch Health Americas, Inc.

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00401362

Brief Title

A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

Official Title

A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

February 2005 (Actual)

Study Completion Date

February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bausch Health Americas, Inc.

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To test the effectiveness of MNTX in advanced illness subjects.

Detailed Description

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

6. Conditions and Keywords

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

Advanced Illness Patients With Opioid Induced Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Placebo Comparator

Arm Title

Arm 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SC Methylnaltrexone

Intervention Description

Dose 1

Intervention Type

Drug

Intervention Name(s)

SC Placebo

Intervention Type

Drug

Intervention Name(s)

SC Methylnaltrexone

Intervention Description

Dose 2

Primary Outcome Measure Information:

Title

Efficacy of SC MNTX compared with placebo in inducing laxation

Description

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Advanced medical illness with a life expectancy of 1 to 6 months No clinically significant laxation within 48 hours prior to the first dose of study drug On stable opioid and laxative regimen for a least 3 days prior to treatment Age greater than 18years Females of child-bearing age must have a negative pregnancy test. Exclusion Criteria: Females who are pregnant or nursing. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC Any disease process suggestive of gastrointestinal obstruction Fecal ostomy.

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

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

27573565

Citation

Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29. Erratum In: Ann Oncol. 2018 Apr 1;29(4):1076.

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

19278178

Citation

Slatkin N, Thomas J, Lipman AG, Wilson G, Boatwright ML, Wellman C, Zhukovsky DS, Stephenson R, Portenoy R, Stambler N, Israel R. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009 Jan-Feb;7(1):39-46.

Results Reference

derived

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A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

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