Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

NCT00858754 | Withdrawn Phase 4

• 1 other identifier: 3200K1-4006
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 7

Brief Summary

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Conditions

Opioid-Induced Constipation

Keywords

opioid induced constipation; Cancer patients; methylnaltrexone

Outcome Measures

Primary Outcomes (1)

• Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.

  1 Day

Secondary Outcomes (1)

• 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.

  2 weeks

Study Arms (2)

Group 1 Active Drug

EXPERIMENTAL

Methylnaltrexone

Drug: methylnaltrexone

Group 2 Non-Active Drug

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

methylnaltrexone DRUG

Also known as: MOA-728

Group 1 Active Drug

placebo DRUG

Also known as: Inactive

Group 2 Non-Active Drug

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a man or woman aged 18 years or older.
• Has a body weight \>= 38 kg.
• Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
• Has a life expectancy of \>= 6 months.
• Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
• Is taking opioids for cancer-related pain, and not just as-needed doses.
• Has a diagnosis of OIC as determined by the investigator.
• Is willing to follow the protocol instructions on laxative use during the study.

You may not qualify if:

• Has a history of chronic constipation before starting opioids.
• Has renal disease receiving dialysis.
• Has an ostomy for stools.
• Is a pregnant or breastfeeding woman.

Sponsors & Collaborators

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

Study Sites (8)

Pfizer Investigational Site

Laguna Hills, California, 92637, United States

Location

Pfizer Investigational Site

Lancaster, California, 93534, United States

Location

Pfizer Investigational Site

Flat Rock, North Carolina, 28731, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Pfizer Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Pfizer Investigational Site

Villejuif, 94804, France

Location

Pfizer Investigational Site

El Palmar, Murcia/Spain, 30120, Spain

Location

Pfizer Investigational Site

Location

Related Links

• To obtain contact information for a study center near you, click here.

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

Study Officials

• Jeff Cohn

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

FR (1); US (4); ES (1); CA (1)