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)

Irritable Bowel Syndrome (IBS) Clinical Trial

— RESTORE  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01887002
• Other study ID #: ONO-2952POU005
• Status: Terminated
• Phase: Phase 2
• First received: June 24, 2013
• Last updated: January 26, 2016
• Start date: June 2013

Study information

• Verified date: January 2016
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Syndrome

Intervention

Drug:
• ONO-2952
ONO-2952 Active tablets, every day for 2 weeks
• Placebo comparator
ONO-2952 Matching Placebo every day for 2 weeks

Locations

Country	Name	City	State
United States	Boston Clinical Site	Boston	Massachusetts
United States	Chapel Hill Clinical Site	Chapel Hill	North Carolina
United States	Oklahoma City Clinical Site	Oklahoma	Oklahoma
United States	St. Louis Clinical Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharma USA Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity rating during rectal distention by using a numeric pain rating scale		2 weeks	No
Secondary	Safety assessed through adverse events and clinical laboratory values		2 weeks	Yes