Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness

NCT00672139 | Completed Phase 4 Results

• 2 other identifiers: 3200K1-4001B2541006
• Study Type: interventional
• Target: 156
• Locations: 10 countries
• Sites: 46

Brief Summary

This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

Conditions

Opioid-Induced Constipation

Keywords

Opioid-Induced Constipation

Outcome Measures

Primary Outcomes (1)

• Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.

  This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.

  10 weeks

Study Arms (1)

Methylnaltrexone bromide

EXPERIMENTAL

Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. 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 bromide

Interventions

Methylnaltrexone bromide DRUG

Also known as: Relistor

Methylnaltrexone bromide

Eligibility Criteria

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

You may qualify if:

• Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
• Is receiving opioids on a regular schedule, not just as needed to control pain.
• Likely to continue to need treatment of OIC for the duration of participation in the study.

You may not qualify if:

• Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
• Currently using an opioid antagonist or partial antagonist.
• Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator

Sponsors & Collaborators

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

Study Sites (46)

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

Orange, New Jersey, 07018, 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

Madison, Wisconsin, 53792, United States

Location

Salix Investigational Site

Coburg, Victoria, 3058, Australia

Location

Salix Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

Salix Investigational Site

Adelaide, 5000, Australia

Location

Salix Investigational Site

Leuven, B-3000, Belgium

Location

Salix Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Salix Investigational Site

Edmonton, Alberta, T6L 5X8, Canada

Location

Salix Investigational Site

Hamilton, Ontario, L8M 1W9, Canada

Location

Salix Investigational Site

London, Ontario, N6A 4L6, Canada

Location

Salix Investigational Site

Montreal, Quebec, H3A 1A1, Canada

Location

Salix Investigational Site

Québec, Quebec, G1R 3S1, Canada

Location

Salix Investigational Site

Montpellier, 34295, France

Location

Salix Investigational Site

Berlin, 14089, Germany

Location

Salix Investigational Site

L’Aquila, 67100, Italy

Location

Salix Investigational Site

Milan, 20020, Italy

Location

Salix Investigational Site

Milan, 20133, Italy

Location

Salix Investigational Site

Roma, 00144, Italy

Location

Pfizer Investigational Site

Mexico City DF, 03600, Mexico

Location

Salix Investigational Site

Almada, 2801-951, Portugal

Location

Salix Investigational Site

Porto, 4200-072, Portugal

Location

Salix Investigational Site

Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom

Location

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 Pharmaceuticals

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 7, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-02

Locations

CA (6); GB (1); AU (3); DE (1); BE (1); US (26); ME (1); FR (1); PT (2); IT (4)