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)

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled 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) (RESTORE)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01887002

Acronym

RESTORE

Enrollment

Registered

2013-06-26

Start date

2013-06-30

Completion date

Unknown

Last updated

2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome, IBS, ONO-2952

Brief summary

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

Interventions

DRUGONO-2952

ONO-2952 Active tablets, every day for 2 weeks

DRUGPlacebo comparator

ONO-2952 Matching Placebo every day for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in pain intensity rating during rectal distention by using a numeric pain rating scale	2 weeks

Secondary

Measure	Time frame
Safety assessed through adverse events and clinical laboratory values	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026