Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D

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Detailed Description

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Conditions

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Irritable Bowel Syndrome (IBS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Arm 1

ONO-2952 Active tablets, every day for 2 weeks

Group Type EXPERIMENTAL

ONO-2952

Intervention Type DRUG

ONO-2952 Active tablets, every day for 2 weeks

Placebo Arm

ONO-2952 Matching Placebo every day for 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

ONO-2952 Matching Placebo every day for 2 weeks

Interventions

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ONO-2952

ONO-2952 Active tablets, every day for 2 weeks

Intervention Type DRUG

Placebo comparator

ONO-2952 Matching Placebo every day for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female 18-65 years of age (inclusive)
2. 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
3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations

Exclusion Criteria

* Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
* History of Chron'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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No