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Status:

COMPLETED

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)

Lead Sponsor:

Ono Pharma USA Inc

Conditions:

Irritable Bowel Syndrome (IBS)

Eligibility:

FEMALE

18-65 years

Phase:

PHASE2

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).

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT01844180

Start Date

April 1 2013

Last Update

April 15 2016

Active Locations (48)

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Page 1 of 12 (48 locations)

1

Anniston Clinical Site

Anniston, Alabama, United States, 36207

2

Goodyear Clinical Site

Goodyear, Arizona, United States, 85351

3

Tucson Clinical Site

Tucson, Arizona, United States, 85712

4

North Little Rock Clinical Site

North Little Rock, Arkansas, United States, 72120