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)

Irritable Bowel Syndrome (IBS) Clinical Trial

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Official title:

A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844180
• Other study ID #: ONO-2952POU004
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2013
• Last updated: January 26, 2016
• Start date: April 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 of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: July 2014
• 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:

1. Improvement with defecation

2. Onset associated with a change in frequency of stool/defecation

3. 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 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

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

Locations

Country	Name	City	State
United States	Akron Clinical Site	Akron	Ohio
United States	Albuquerque Clinical Site	Albuquerque	New Mexico
United States	Anniston Clinical Site	Anniston	Alabama
United States	Billings Clinical Site	Billings	Montana
United States	Boynton Beach Clinical Site	Boynton Beach	Florida
United States	Carlsbad Clinical Site	Carlsbad	California
United States	Cary Clinical Site	Cary	North Carolina
United States	Chattanooga Clinical Site	Chattanooga	Tennessee
United States	Chesterfield Clincial Site	Chesterfield	Michigan
United States	Clearwater Clinical Site	Clearwater	Florida
United States	Columbus Clinical Site	Columbus	Ohio
United States	Dayton Clinical Site	Dayton	Ohio
United States	Deland Clinical Site	Deland	Florida
United States	Germantown Clinical Site	Germantown	Tennessee
United States	Goodyear Clinical Site	Goodyear	Arizona
United States	Great Neck Clinical Site	Great Neck	New York
United States	Greer Clinical Site	Greer	South Carolina
United States	Groveport Clinical Site	Groveport	Ohio
United States	Hialeah Clinical Site	Hialeah	Florida
United States	Highpoint Clinical Site	Highpoint	North Carolina
United States	Lansdale Clinical Site	Landsdale	Pennsylvania
United States	Lauderdale Lakes Clinical Site	Lauderdale Lakes	Florida
United States	Lebanon Clinical Site	Lebanon	New Hampshire
United States	Logan Clinical Site	Logan	Utah
United States	Mentor Clinical Site	Mentor	Ohio
United States	Mt. Pleasant Clinical Site	Mt. Pleasant	South Carolina
United States	New Orleans Clinical Site	New Orleans	Louisiana
United States	Norman Clinical Site	Norman	Oklahoma
United States	North Little Rock Clinical Site	North Little Rock	Arkansas
United States	Oak Lawn Clinical Site	Oak Lawn	Illinois
United States	Ogden Clinical Site	Ogden	Utah
United States	Orlando Clinical Site	Orlando	Florida
United States	Pasadena Clinical Site	Pasadena	Texas
United States	Plano Clinial Site	Plano	Texas
United States	Port Orange Clinical Site	Port Orange	Florida
United States	Raleigh Clinical Site	Raleigh	North Carolina
United States	Reno Clinical Site	Reno	Nevada
United States	Salt Lake City Clinical Site	Salt Lake City	Utah
United States	San Antonio Clinical Site	San Antonio	Texas
United States	San Diego Clinical Site	San Diego	California
United States	Sandy Clinical Site	Sandy	Utah
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	Tucson Clinical Site	Tucson	Arizona
United States	West Palm Clinical Site	West Palm	Florida
United States	Wichita Clinical Site	Wichita	Kansas
United States	Winston-Salem Clinical Site	Winston-Salem	North Carolina

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	Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)		4 weeks	No
Secondary	Change in IBS related symptoms and quality of life (QoL) by questionaire assessments		4 weeks	No
Secondary	Safety assessed through adverse events and clinical laboratory values		4 weeks	Yes