Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

Phase 3

Completed

Conditions: Opioid-Induced Bowel Dysfunction

Interventions: Drug: Placebo
Drug: Lubiprostone

Registration Number: NCT00595946

Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary: The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 439

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0 mcg capsules twice daily (BID)
Lubiprostone	Lubiprostone	24 mcg capsules twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Mean Weekly Spontaneous Bowel Movements at Week 8	at Week 8	Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.

Secondary Outcome Measures

Name	Time	Method
Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks	within 12 weeks	Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12
Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose	within 48 hours post-dose	The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.
Number of Participants Classified as Responders	within 12 weeks	Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.
Participant Reported Outcome of Treatment Effectiveness	within 12 weeks	Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.
Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity	within 12 weeks	Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline. Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best; Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse

Trial Locations

Locations (93): The Birmingham Pain Center
🇺🇸
Birmingham, Alabama, United States
Simon Williamson Clinic, PC
🇺🇸
Hueytown, Alabama, United States
Alabama Orthopedic Clinic
🇺🇸
Mobile, Alabama, United States
Clinical Research Advantage, Inc./ Mesa Family Medical Center
🇺🇸
Mesa, Arizona, United States
Clinical Research Advantage, Inc.
🇺🇸
Tempe, Arizona, United States
Harmony Clinical Research, Inc.
🇺🇸
Tucson, Arizona, United States
Verona Clinical Research, Inc.
🇺🇸
Tucson, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸
Tucson, Arizona, United States
Genova Clinical Research, Inc.
🇺🇸
Tucson, Arizona, United States
Pusch Ridge Family Medicine / WC Clinical Research
🇺🇸
Tucson, Arizona, United States
Scroll for more (83 remaining)
The Birmingham Pain Center
🇺🇸Birmingham, Alabama, United States