A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,246
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
Study Overview
Brief Summary
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Naldemedine
Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
Intervention: Naldemedine (Drug)
Placebo
Participants received matching placebo tablets orally once daily for 52 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: From the first dose of study drug up to 14 days after the last dose of study drug (54 weeks).
A serious adverse event was defined as any adverse event (AE) that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization were considered an SAE when, based upon appropriate medical judgment, they jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Adverse drug reactions (ADRs) were defined as adverse events that were considered by the investigator to be definitely, probably, or possibly related to study drug. Serious ADRs were defined as serious AEs considered by the investigator to be definitely, probably, or possibly related to study drug.
Secondary Outcomes
- Change From Baseline in the Number of Bowel Movements Per Week(Baseline and Weeks 12, 24, 36, and 52)
- Change From Baseline in the Overall Score for Patient Assessment of Constipation Symptoms(Baseline and Weeks 2, 12, 24, 36, and 52)
- Change From Baseline in the PAC-SYM Rectal-symptoms Domain Score(Baseline and Weeks 2, 12, 24, 36, and 52)
- Change From Baseline in the PAC-SYM Stool-symptoms Domain Score(Baseline and Weeks 2, 12, 24, 36, and 52)
- Percentage of Participants Meeting Each Criterion of Laxative Use(From 28 days prior to screening until the end of the treatment period (total of 56 weeks))
- Change From Baseline in the PAC-SYM Abdominal-symptoms Domain Score(Baseline and Weeks 2, 12, 24, 36, and 52)
- Change From Baseline in the Physical Discomfort Domain of PAC-QOL(Baseline and Weeks 2, 12, 24, 36, and 52)
- Change From Baseline in the Satisfaction Domain of PAC-QOL(Baseline and Weeks 2, 12, 24, 36, and 52)
- Change From Baseline in the Patient Assessment of Constipation Quality of Life Overall Score(Baseline and Weeks 2, 12, 24, 36, and 52)
- Change From Baseline in the Psychosocial Discomfort Domain of PAC-QOL(Baseline and Weeks 2, 12, 24, 36, and 52)
- Change From Baseline in the Worries and Concerns Domain of PAC-QOL(Baseline and Weeks 2, 12, 24, 36, and 52)
- Participant Global Satisfaction(Week 52 or early termination visit)