Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

NCT00804141

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35242, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Constipation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women 18 years or older.

- A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.

- A history of constipation due to opioid use during 1 month before the screening visit.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction,
fecal incontinence or rectal prolapse.


- A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon
within 6 months before the screening visit.


- A history of malignancy, other than basal cell or squamous cell skin carcinoma, within
5 years before the screening visit.


- A history of chronic constipation before initiation of opioid therapy.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Official Title  ICMJE An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain
Brief Summary This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE Drug: N-methylnaltrexone bromide (MOA-728)
MOA-728 will be administered as per the dose and schedule specified in the arm.
Other Name: Relistor
Study Arms  ICMJE Experimental: MOA-728 12 mg QD
Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.
Intervention: Drug: N-methylnaltrexone bromide (MOA-728)
Publications * Webster R, Michna E, Khan A, et al., The long-term efficacy of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain. J. Pain, 12(4), Supplement , Page P70, April 2011

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2010)
1040
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2008)
800
Actual Study Completion Date  ICMJE September 20, 2010
Actual Primary Completion Date September 20, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women 18 years or older.
  • A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
  • A history of constipation due to opioid use during 1 month before the screening visit.

Exclusion Criteria:

  • A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
  • A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
  • A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
  • A history of chronic constipation before initiation of opioid therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Colombia,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00804141
Other Study ID Numbers  ICMJE 3200K1-3358
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Lindsey MathewBausch Health Americas, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP