Study of Methylnaltrexone (MNTX) for the Relief of Constipation

NCT00402038 | Completed Phase 3 DMC

• 1 other identifier: MNTX 302
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Conditions

Advance Illness Patients With OIC

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: SC Methylnaltrexone

Arm 2

PLACEBO COMPARATOR

Drug: SC Placebo

Interventions

SC Methylnaltrexone DRUG

Dose 1

Arm 1

SC Placebo DRUG

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

Related Publications (5)

• 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.

  PMID: 33788162 DERIVED

• 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.

  PMID: 31951150 DERIVED

• 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.

  PMID: 24815199 DERIVED

• 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.

  PMID: 21657861 DERIVED

• 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.

  PMID: 18509120 DERIVED

Related Links

• Related Info

Study Officials

• Tage Ramakrishna, MD

  Progenics Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: February 1, 2004
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (1)