Phase 3
N=439
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Opioid-Induced Bowel Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00620061 ↗Enrolled (actual)
439
Serious AEs
7.7%
Results posted
Dec 2019
Primary outcome: Primary: Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month — 1.4; 4.9; 4.9; 5.0 Weekly SBMs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lubiprostone 24 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sucampo Pharma Americas, LLC
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month |
1.4; 4.9; 4.9; 5.0; 5.0; 5.0 | — |
| PRIMARY Mean Weekly Bowel Movements (BMs) Per Month |
2.4; 5.0; 5.0; 5.2; 5.1; 5.1 | — |
| SECONDARY Number of Participants Classified as Monthly Responders |
322; 323; 291; 270; 259; 250 | — |
| SECONDARY Straining Associated With Spontaneous Bowel Movements by Month |
2.7; 1.7; 1.7; 1.6; 1.7; 1.6 | — |
| SECONDARY Stool Consistency of Spontaneous Bowel Movements by Month |
3.0; 2.3; 2.2; 2.2; 2.2; 2.2 | — |
| SECONDARY Constipation Severity by Month |
2.4; 1.5; 1.5; 1.5; 1.5; 1.4 | — |
| SECONDARY Abdominal Bloating by Month |
2.2; 1.6; 1.5; 1.5; 1.5; 1.5 | — |
| SECONDARY Abdominal Discomfort by Month |
2.2; 1.5; 1.4; 1.4; 1.4; 1.4 | — |
| SECONDARY Bowel Habit Regularity by Month |
4.7; 3.6; 3.6; 3.5; 3.5; 3.5 | — |
| SECONDARY Treatment Effectiveness by Month |
2.1; 2.1; 2.2; 2.2; 2.2; 2.2 | — |
| SECONDARY Mean Weekly Complete SBMs by Month |
3.1; 3.4; 3.6; 3.6; 3.7; 3.7 | — |
| SECONDARY Mean Weekly Complete BMs by Month |
3.1; 3.4; 3.6; 3.7; 3.8; 3.8 | — |
Summary
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
Eligibility Criteria
Inclusion Criteria
- Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
- Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
- Willing to continue to abstain from use of disallowed medications as defined per protocol
Exclusion Criteria
- Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]
- Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.
- Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Data sourced from ClinicalTrials.gov (NCT00620061). 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.