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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00804141
Recruitment Status : Completed
First Posted : December 8, 2008
Results First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE December 5, 2008
First Posted Date  ICMJE December 8, 2008
Results First Submitted Date  ICMJE September 27, 2019
Results First Posted Date  ICMJE October 18, 2019
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE December 3, 2008
Actual Primary Completion Date September 20, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Week 50 ]
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2008)
collection of safety data & assessments to include monitoring of treatment emergent adverse events, safety laboratory measurements, electrocardiograms and changes in the physical exam including vital signs while on therapy [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up [ Time Frame: Baseline, follow-up (14 days [Week 49 to 50]) ]
Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2008)
change in bowel function compared to baseline [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Mathew Bausch 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