Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
- Registration Number
- NCT02544152
- Lead Sponsor
- Sucampo Pharma Americas, LLC
- Brief Summary
A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
- Detailed Description
To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily \[BID\]) in subjects diagnosed with IBS-M/IBS-U.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 71
- Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III Diagnostic Questionnaire for Adult Functional GI Disorders.
- Subject Screening diary entries must show an average worst abdominal pain in the past 24 hours score of at least 4 on a 11-point scale.
- Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors if taking antidepressants.
- Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation (IBS-C), according to Rome III Criteria.
- Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or defecation.
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants receive 0 mcg capsules BID Lubiprostone Lubiprostone Participants receive 8 mcg lubiprostone capsules twice daily (BID)
- Primary Outcome Measures
Name Time Method Number of Participants Classified as an Overall Responder for Abdominal Pain within 12 weeks An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.
- Secondary Outcome Measures
Name Time Method Number of Participants Classified as a Monthly Responder for Abdominal Pain within 3 months A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month.
Number of Participants Classified as a Monthly Responder for Stool Consistency within 3 months A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month.
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms within 12 weeks A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms.
Number of Participants Classified as a Monthly Responder for IBS Symptoms within 3 months A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms.
Number of Participants Classified as a Weekly Responder for Abdominal Pain within 12 weeks Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse.
A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week.Number of Participants Classified as an Overall Responder for IBS Symptoms within 3 months A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms.
Number of Participants Classified as an Overall Responder for Stool Consistency within 3 months An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks.
Number of Participants Classified as a Weekly Responder for Stool Consistency within 12 weeks A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week.
Trial Locations
- Locations (15)
E Squared Research, Inc.
🇺🇸Huntsville, Alabama, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Houston Endoscopy Research Center
🇺🇸Houston, Texas, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Meritus Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
Prestige Clinical Research Center
🇺🇸Miami, Florida, United States
GW Research Inc.
🇺🇸Chula Vista, California, United States
PMG Research of Charlotte
🇺🇸Concord, North Carolina, United States
Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Advanced Clinical Research Associates
🇺🇸Plano, Texas, United States
Wellness Clinical Research Associates
🇺🇸McKinney, Texas, United States