A Phase 2, Multi-center Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
- Conditions
- Irritable Bowel Syndrome (IBS)
- Interventions
- Registration Number
- NCT01844180
- Lead Sponsor
- Ono Pharma USA Inc
- Brief Summary
The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
-
Female 18-65 years of age (inclusive)
-
Diagnosed with IBS based on the following criteria (Rome III criteria):
-
Symptom onset at least 6 months prior to diagnosis, and
-
Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
-
Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
- Improvement with defecation
- Onset associated with a change in frequency of stool/defecation
- Onset associated with a change in form (appearance) of stool
-
-
Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
- Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
- History of Crohn's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Arm ONO-2952 Matching Placebo ONO-2952 Matching Placebo every day for 4 weeks Experimental Arm 1 ONO-2952 ONO-2952 low dose every day for 4 weeks Experimental Arm 2 ONO-2952 ONO-2952 high dose every day for 4 weeks
- Primary Outcome Measures
Name Time Method Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS) 4 weeks
- Secondary Outcome Measures
Name Time Method Safety assessed through adverse events and clinical laboratory values 4 weeks Change in IBS related symptoms and quality of life (QoL) by questionaire assessments 4 weeks
Trial Locations
- Locations (48)
Billings Clinical Site
🇺🇸Billings, Montana, United States
Goodyear Clinical Site
🇺🇸Goodyear, Arizona, United States
Chattanooga Clinical Site
🇺🇸Chattanooga, Tennessee, United States
Germantown Clinical Site
🇺🇸Germantown, Tennessee, United States
Chesterfield Clincial Site
🇺🇸Chesterfield, Michigan, United States
Anniston Clinical Site
🇺🇸Anniston, Alabama, United States
Clearwater Clinical Site
🇺🇸Clearwater, Florida, United States
Orlando Clinical Site
🇺🇸Orlando, Florida, United States
Lauderdale Lakes Clinical Site
🇺🇸Lauderdale Lakes, Florida, United States
Deland Clinical Site
🇺🇸Deland, Florida, United States
West Palm Clinical Site
🇺🇸West Palm, Florida, United States
Boynton Beach Clinical Site
🇺🇸Boynton Beach, Florida, United States
Sandy Clinical Site
🇺🇸Sandy, Utah, United States
Great Neck Clinical Site
🇺🇸Great Neck, New York, United States
Groveport Clinical Site
🇺🇸Groveport, Ohio, United States
St. Petersburg Clinical Site
🇺🇸St. Petersburg, Florida, United States
Ogden Clinical Site
🇺🇸Ogden, Utah, United States
Lansdale Clinical Site
🇺🇸Landsdale, Pennsylvania, United States
Mt. Pleasant Clinical Site
🇺🇸Mt. Pleasant, South Carolina, United States
Cary Clinical Site
🇺🇸Cary, North Carolina, United States
Port Orange Clinical Site
🇺🇸Port Orange, Florida, United States
South Miami Clinical Site
🇺🇸South Miami, Florida, United States
Mentor Clinical Site
🇺🇸Mentor, Ohio, United States
Reno Clinical Site
🇺🇸Reno, Nevada, United States
Logan Clinical Site
🇺🇸Logan, Utah, United States
Raleigh Clinical Site
🇺🇸Raleigh, North Carolina, United States
Akron Clinical Site
🇺🇸Akron, Ohio, United States
Greer Clinical Site
🇺🇸Greer, South Carolina, United States
Columbus Clinical Site
🇺🇸Columbus, Ohio, United States
San Diego Clinical Site
🇺🇸San Diego, California, United States
Norman Clinical Site
🇺🇸Norman, Oklahoma, United States
San Antonio Clinical Site
🇺🇸San Antonio, Texas, United States
Wichita Clinical Site
🇺🇸Wichita, Kansas, United States
Salt Lake City Clinical Site
🇺🇸Salt Lake City, Utah, United States
Tampa Clinical Site
🇺🇸Tampa, Florida, United States
Hialeah Clinical Site
🇺🇸Hialeah, Florida, United States
North Little Rock Clinical Site
🇺🇸North Little Rock, Arkansas, United States
Carlsbad Clinical Site
🇺🇸Carlsbad, California, United States
Lebanon Clinical Site
🇺🇸Lebanon, New Hampshire, United States
Oak Lawn Clinical Site
🇺🇸Oak Lawn, Illinois, United States
Highpoint Clinical Site
🇺🇸Highpoint, North Carolina, United States
Dayton Clinical Site
🇺🇸Dayton, Ohio, United States
Plano Clinial Site
🇺🇸Plano, Texas, United States
Pasadena Clinical Site
🇺🇸Pasadena, Texas, United States
New Orleans Clinical Site
🇺🇸New Orleans, Louisiana, United States
Albuquerque Clinical Site
🇺🇸Albuquerque, New Mexico, United States
Winston-Salem Clinical Site
🇺🇸Winston-Salem, North Carolina, United States
Tucson Clinical Site
🇺🇸Tucson, Arizona, United States