Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
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|ClinicalTrials.gov Identifier: NCT00804141|
Recruitment Status : Completed
First Posted : December 8, 2008
Results First Posted : October 18, 2019
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: N-methylnaltrexone bromide (MOA-728)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1040 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Study Director:||Lindsey Mathew||Bausch Health Americas, Inc.|