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

NCT00401362 | Completed Phase 3 DMC

• 1 other identifier: MNTX 301
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

To test the effectiveness of MNTX in advanced illness subjects.

Conditions

Advanced Illness Patients With Opioid Induced Constipation

Outcome Measures

Primary Outcomes (1)

• 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.

  29 days

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: SC Methylnaltrexone

Arm 3

PLACEBO COMPARATOR

Drug: SC Placebo

Arm 2

EXPERIMENTAL

Drug: SC Methylnaltrexone

Interventions

SC Methylnaltrexone DRUG

Dose 1

Arm 1

SC Placebo DRUG

Arm 3

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Pfizer: collaborator

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

Related Publications (4)

• 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

• 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.

  PMID: 27573565 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

• 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.

  PMID: 19278178 DERIVED

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 16, 2006
• First Posted: November 20, 2006
• Study Start: February 1, 2003
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (1)