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

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00858754

Collaborator

Progenics Pharmaceuticals, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-Induced Constipation	Drug: methylnaltrexone Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Active Drug Methylnaltrexone	Drug: methylnaltrexone Other Names: MOA-728
Placebo Comparator: Group 2 Non-Active Drug Placebo	Drug: placebo Other Names: Inactive

Arm

Intervention/Treatment

Experimental: Group 1 Active Drug

Methylnaltrexone

Drug: methylnaltrexone

Other Names:

MOA-728

Placebo Comparator: Group 2 Non-Active Drug

Placebo

Drug: placebo

Other Names:

Inactive

Outcome Measures

Primary Outcome Measures

Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. [1 Day]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Laguna Hills	California	United States	92637
2	Pfizer Investigational Site	Lancaster	California	United States	93534
3	Pfizer Investigational Site	Flat Rock	North Carolina	United States	28731
4	Pfizer Investigational Site	Madison	Wisconsin	United States	53792
5	Pfizer Investigational Site	Edmonton	Alberta	Canada	T6G 1Z2
6	Pfizer Investigational Site	Villejuif Cedex		France	94804
7	Pfizer Investigational Site	El Palmar	Murcia/Spain	Spain	30120
8	Pfizer Investigational Site