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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome (IBS)

In brief

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).

Key facts

Study ID

NCT01844180

Run by

Ono Pharma USA Inc

People needed

200

Starts

2013-04-01

Last updated by the study team

2016-04-15

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anniston Clinical Site — Anniston, Alabama, United States
• Goodyear Clinical Site — Goodyear, Arizona, United States
• Tucson Clinical Site — Tucson, Arizona, United States
• North Little Rock Clinical Site — North Little Rock, Arkansas, United States
• Carlsbad Clinical Site — Carlsbad, California, United States
• San Diego Clinical Site — San Diego, California, United States
• Boynton Beach Clinical Site — Boynton Beach, Florida, United States
• Clearwater Clinical Site — Clearwater, Florida, United States
• Deland Clinical Site — DeLand, Florida, United States
• Hialeah Clinical Site — Hialeah, Florida, United States
• Lauderdale Lakes Clinical Site — Lauderdale Lakes, Florida, United States
• Orlando Clinical Site — Orlando, Florida, United States
• Port Orange Clinical Site — Port Orange, Florida, United States
• South Miami Clinical Site — South Miami, Florida, United States
• St. Petersburg Clinical Site — St. Petersburg, Florida, United States
• Tampa Clinical Site — Tampa, Florida, United States
• West Palm Clinical Site — West Palm, Florida, United States
• Oak Lawn Clinical Site — Oak Lawn, Illinois, United States
• Wichita Clinical Site — Wichita, Kansas, United States
• New Orleans Clinical Site — New Orleans, Louisiana, United States
• Chesterfield Clincial Site — Chesterfield, Michigan, United States
• Billings Clinical Site — Billings, Montana, United States
• Reno Clinical Site — Reno, Nevada, United States
• Lebanon Clinical Site — Lebanon, New Hampshire, United States
• Albuquerque Clinical Site — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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