Phase 3
N=1,246
Long Term Safety of Naldemedine
Opioid-induced Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01965652 ↗Enrolled (actual)
1,246
Serious AEs
10.7%
Results posted
May 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 425; 446; 149; 121 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naldemedine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shionogi
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
425; 446; 149; 121; 39; 36 | — |
| SECONDARY Change From Baseline in the Number of Bowel Movements Per Week |
3.70; 2.42; 3.77; 2.77; 3.88; 2.88 | <0.0001 sig |
| SECONDARY Percentage of Participants Meeting Each Criterion of Laxative Use |
30.0; 29.5; 7.0; 13.1; 50.2; 54.0 | — |
| SECONDARY Change From Baseline in the Overall Score for Patient Assessment of Constipation Symptoms |
-1.15; -0.81; -1.11; -0.86; -1.16; -0.87 | <0.0001 sig |
| SECONDARY Change From Baseline in the PAC-SYM Abdominal-symptoms Domain Score |
-0.99; -0.79; -0.93; -0.78; -0.99; -0.81 | 0.0002 sig |
| SECONDARY Change From Baseline in the PAC-SYM Rectal-symptoms Domain Score |
-1.00; -0.75; -0.97; -0.81; -1.02; -0.79 | <0.0001 sig |
| SECONDARY Change From Baseline in the PAC-SYM Stool-symptoms Domain Score |
-1.37; -0.86; -1.34; -0.96; -1.37; -0.97 | <0.0001 sig |
| SECONDARY Change From Baseline in the Patient Assessment of Constipation Quality of Life Overall Score |
-1.14; -0.75; -1.19; -0.83; -1.19; -0.86 | <0.0001 sig |
| SECONDARY Change From Baseline in the Physical Discomfort Domain of PAC-QOL |
-1.33; -0.94; -1.27; -0.95; -1.26; -0.98 | <0.0001 sig |
| SECONDARY Change From Baseline in the Psychosocial Discomfort Domain of PAC-QOL |
-0.92; -0.69; -0.96; -0.72; -0.97; -0.72 | <0.0001 sig |
| SECONDARY Change From Baseline in the Worries and Concerns Domain of PAC-QOL |
-1.14; -0.74; -1.21; -0.85; -1.19; -0.87 | <0.0001 sig |
| SECONDARY Change From Baseline in the Satisfaction Domain of PAC-QOL |
-1.37; -0.70; -1.45; -0.87; -1.50; -0.99 | <0.0001 sig |
| SECONDARY Participant Global Satisfaction |
2.4; 2.0; 0.6; 2.8; 1.0; 2.2 | <0.0001 sig |
Summary
The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
Eligibility Criteria
Inclusion Criteria
- Subjects aged 18 to 80 years inclusive at the time of informed consent
- Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (OIC)
- Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
- Subjects may or may not be on a routine laxative regimen at the time of Screening
Exclusion Criteria
- Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
- Evidence of active medical diseases affecting bowel transit
- History of pelvic disorders that may be a cause of constipation
- Surgery (except for minor procedures) within 60 days of Screening
- History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical GI obstruction)
- Subjects who have never taken laxatives for the treatment of OIC
- Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists
Data sourced from ClinicalTrials.gov (NCT01965652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.