Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

NCT00672477 | Completed Phase 4 Results

• 2 other identifiers: 3200K1-4000B2541005
• Study Type: interventional
• Target: 237
• Locations: 12 countries
• Sites: 60

Brief Summary

This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

Conditions

Opioid-Induced Constipation

Keywords

opioid-induced constipation

Outcome Measures

Primary Outcomes (1)

• The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses

  This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.

  7 days

Secondary Outcomes (1)

• Time to First Rescue-free Laxation (Following the First Dose of Study Drug).

  14 days

Study Arms (2)

Methylnaltrexone

EXPERIMENTAL

Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and \<62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.

Drug: Methylnaltrexone

Placebo

PLACEBO COMPARATOR

Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and \< 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.

Drug: Placebo

Interventions

Methylnaltrexone DRUG

Also known as: MOA-728, Relistor

Methylnaltrexone

Placebo DRUG

Also known as: Control

Placebo

Eligibility Criteria

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

You may qualify if:

• Is an adult 18 years of age or older
• Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
• Has a life expectancy of at least 1 month.
• Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
• Has constipation that is caused by opioid medications.

You may not qualify if:

• Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
• Has a known or suspected mechanical gastrointestinal obstruction.
• Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
• Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
• Receiving opioid antagonist or partial antagonist products.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (60)

Salix Investigational Site

Mobile, Alabama, 36604, United States

Location

Salix Investigational Site

Laguna Hills, California, 92637, United States

Location

Salix Investigational Site

Lancaster, California, 93534, United States

Location

Salix Investigational Site

Aurora, Colorado, 80045, United States

Location

Salix Investigational Site

Auburndale, Florida, 33823, United States

Location

Salix Investigational Site

Hudson, Florida, 34667, United States

Location

Salix Investigational Site

Lakeland, Florida, 33805, United States

Location

Salix Investigational Site

Lakeland, Florida, 33815, United States

Location

Salix Investigational Site

Miami Springs, Florida, 33166, United States

Location

Salix Investigational Site

Ruskin, Florida, 33573, United States

Location

Salix Investigational Site

Sebring, Florida, 33870, United States

Location

Salix Investigational Site

Tampa, Florida, 33609, United States

Location

Salix Investigational Site

Tampa, Florida, 33612-9416, United States

Location

Salix Investigational Site

Tampa, Florida, 33619, United States

Location

Salix Investigational Site

Temple Terrace, Florida, 33617, United States

Location

Salix Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Salix Investigational Site

Orange, New Jersey, 07018, United States

Location

Salix Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

Salix Investigational Site

Flat Rock, North Carolina, 28731, United States

Location

Salix Investigational Site

Winston-Salem, North Carolina, 27103-5766, United States

Location

Salix Investigational Site

Cleveland, Ohio, 44119, United States

Location

Salix Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Salix Investigational Site

Austin, Texas, 78757, United States

Location

Salix Investigational Site

Houston, Texas, 77030, United States

Location

Salix Investigational Site

American Fork, Utah, 84003, United States

Location

Salix Investigational Site

Orem, Utah, 84058, United States

Location

Salix Investigational Site

Provo, Utah, 84604, United States

Location

Salix Investigational Site

Salt Lake City, Utah, 84112, United States

Location

Salix Investigational Site

Madison, Wisconsin, 53792, United States

Location

Salix Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Salix Investigational Site

Coburg, Victoria, 3058, Australia

Location

Salix Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

Salix Investigational Site

Leuven, B-3000, Belgium

Location

Salix Investigational Site

Liberdade, São Paulo, 01509-900, Brazil

Location

Salix Investigational Site

São Paulo, São Paulo, 01508-010, Brazil

Location

Salix Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Salix Investigational Site

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Salix Investigational Site

Hamilton, Ontario, L8M 1W9, Canada

Location

Salix Investigational Site

Montreal, Quebec, H3A 1A1, Canada

Location

Salix Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Salix Investigational Site

Québec, Quebec, G1R 3S1, Canada

Location

Salix Investigational Site

Besançon, 25030, France

Location

Salix Investigational Site

Bordeaux, 33075, France

Location

Salix Investigational Site

Bordeaux, 33604, France

Location

Salix Investigational Site

Grenoble, 38043, France

Location

Salix Investigational Site

Montpellier, 34295, France

Location

Salix Investigational Site

Villejuif, 94804, France

Location

Salix Investigational Site

Aachen, 52074, Germany

Location

Salix Investigational Site

Berlin, 14089, Germany

Location

Salix Investigational Site

München, 80336, Germany

Location

Salix Investigational Site

L’Aquila, 67100, Italy

Location

Salix Investigational Site

Milan, 20020, Italy

Location

Salix Investigational Site

Milan, 20133, Italy

Location

Pfizer Investigational Site

Mexico City DF, 03600, Mexico

Location

Salix Investigational Site

Barcelona, 08036, Spain

Location

Salix Investigational Site

L'Hospitalet de Llobregat, 8097, Spain

Location

Salix Investigational Site

Seville, 41013, Spain

Location

Salix Investigational Site

Kungsbacka, 434 80, Sweden

Location

Salix Investigational Site

Norrköping, 60185, Sweden

Location

Salix Investigational Site

Cheltenham, Gloucestershire, GL53 0Qj, United Kingdom

Location

Related Publications (2)

• 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

• 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

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: David Sorscher
• Organization: Salix

david.sorscher@salix.com

919-862-1827

Study Officials

• Enoch Bortey

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 8, 2018
• Results First Posted: March 8, 2018

Record last verified: 2018-02

Locations

BE (1); CA (6); FR (6); IT (3); SE (2); DE (3); ME (1); AU (3); GB (1); ES (3); US (29); BR (2)