Phase 3
Completed N=439
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
Opioid-induced Bowel Dysfunction
Source: ClinicalTrials.gov NCT01298219 ↗
Enrolled (actual)
439
Serious AEs
3.0%
Results posted
Dec 2019
Primary outcomePrimary: Number of Participants Classified as Treatment Responders Within 12 Weeks — 59; 41 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Classified as Treatment Responders Within 12 Weeks |
59; 41 | — |
| SECONDARY Number of SBMs Per Week at Week 8 |
2.9; 2.5 | — |
| SECONDARY Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation |
110; 84; 157; 134 | — |
| SECONDARY Number of SBMs Per Week at Week 12 |
3.1; 2.7 | — |
| SECONDARY Number of SBMs Per Week Overall |
4.3; 3.7 | — |
Eligibility Criteria
Inclusion Criteria
A patient can be considered for eligibility to participate if he/she:
- Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
- Is diagnosed with OBD
- Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
- Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study
Exclusion Criteria
A patient cannot be considered for eligibility to participate if he/she:
- Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
Data sourced from ClinicalTrials.gov (NCT01298219). 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. Informational only — not medical advice.