Phase 3
N=439
Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone
Opioid-Induced Bowel Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00595946 ↗Enrolled (actual)
439
Serious AEs
4.6%
Results posted
Feb 2016
Primary outcome: Primary: Mean Weekly Spontaneous Bowel Movements at Week 8 — 2.4; 3.2 SBMs/Week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lubiprostone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sucampo Pharma Americas, LLC
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Weekly Spontaneous Bowel Movements at Week 8 |
2.4; 3.2 | — |
| SECONDARY Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks |
2.2; 2.8; 2.1; 2.7 | — |
| SECONDARY Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose |
65; 89; 116; 138 | — |
| SECONDARY Number of Participants Classified as Responders |
87; 103 | — |
| SECONDARY Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity |
-0.6; -1.0; -0.5; -0.8; -0.4; -0.6 | — |
| SECONDARY Participant Reported Outcome of Treatment Effectiveness |
1.3; 1.6 | — |
Summary
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.
Eligibility Criteria
Inclusion Criteria
- Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
- Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening period.
- If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
- Use of prescribed or Over-the-Counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
- If treated for clinical depression with Selective serotonin reuptake inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
- Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.
Exclusion Criteria
- Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
- Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
- Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
- Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
- Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
- Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
- Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
Data sourced from ClinicalTrials.gov (NCT00595946). 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.