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

• 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: Bausch Health Americas, Inc.
• Collaborator: Pfizer
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Tracking Information

• First Submitted Date: December 5, 2008
• First Posted Date: December 8, 2008
• Results First Submitted Date: September 27, 2019
• Results First Posted Date: October 18, 2019
• Last Update Posted Date: October 18, 2019
• Actual Study Start Date: December 3, 2008
• Actual Primary Completion Date: September 20, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Constipation

Intervention

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

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 *: Michna E, Blonsky ER, Schulman S, Tzanis E, Manley A, Zhang H, Iyer S, Randazzo B. Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. J Pain. 2011 May;12(5):554-62. doi: 10.1016/j.jpain.2010.11.008. Epub 2011 Mar 22.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2010): 1040
• Original Estimated Enrollment (submitted: December 5, 2008): 800
• Actual Study Completion Date: September 20, 2010
• Actual Primary Completion Date: September 20, 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, Colombia, Korea, Republic of, Spain, United States

Administrative Information

• NCT Number: NCT00804141
• Other Study ID Numbers: 3200K1-3358
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bausch Health Americas, Inc.
• Study Sponsor: Bausch Health Americas, Inc.
• Collaborators: Pfizer

Investigators

• Study Director: Lindsey Mathew; Bausch Health Americas, Inc.

• PRS Account: Bausch Health Americas, Inc.
• Verification Date: September 2019