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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.

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.

Condition or disease Intervention/treatment Phase
Constipation Drug: N-methylnaltrexone bromide (MOA-728) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1040 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 3, 2008
Actual Primary Completion Date : September 20, 2010
Actual Study Completion Date : September 20, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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.
Drug: N-methylnaltrexone bromide (MOA-728)
MOA-728 will be administered as per the dose and schedule specified in the arm.
Other Name: Relistor




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804141


Locations
Show Show 120 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Pfizer
Investigators
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Study Director: Lindsey Mathew Bausch Health Americas, Inc.
Additional Information:
Publications of Results:
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

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00804141    
Other Study ID Numbers: 3200K1-3358
First Posted: December 8, 2008    Key Record Dates
Results First Posted: October 18, 2019
Last Update Posted: October 18, 2019
Last Verified: September 2019
Keywords provided by Bausch Health Americas, Inc.:
treatment for opioid-induced constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bromides
Methylnaltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents