Clinical trial NCT01844180: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Irritable Bowel Syndrome
IBS
ONO-2952
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in IBS related symptoms and quality of life (QoL) by questionaire assessments
timeFrame: 4 weeks
measure: Safety assessed through adverse events and clinical laboratory values
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Anniston Clinical Site
state: Alabama
city: Goodyear
country: United States
facility: Goodyear Clinical Site
state: Arizona
city: Tucson
country: United States
facility: Tucson Clinical Site
state: Arizona
city: North Little Rock
country: United States
facility: North Little Rock Clinical Site
state: Arkansas
city: Carlsbad
country: United States
facility: Carlsbad Clinical Site
state: California
city: San Diego
country: United States
facility: San Diego Clinical Site
state: California
city: Boynton Beach
country: United States
facility: Boynton Beach Clinical Site
state: Florida
city: Clearwater
country: United States
facility: Clearwater Clinical Site
state: Florida
city: Deland
country: United States
facility: Deland Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Hialeah Clinical Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Lauderdale Lakes Clinical Site
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Site
state: Florida
city: Port Orange
country: United States
facility: Port Orange Clinical Site
state: Florida
city: South Miami
country: United States
facility: South Miami Clinical Site
state: Florida
city: St. Petersburg
country: United States
facility: St. Petersburg Clinical Site
state: Florida
city: Tampa
country: United States
facility: Tampa Clinical Site
state: Florida
city: West Palm
country: United States
facility: West Palm Clinical Site
state: Florida
city: Oak Lawn
country: United States
facility: Oak Lawn Clinical Site
state: Illinois
city: Wichita
country: United States
facility: Wichita Clinical Site
state: Kansas
city: New Orleans
country: United States
facility: New Orleans Clinical Site
state: Louisiana
city: Chesterfield
country: United States
facility: Chesterfield Clincial Site
state: Michigan
city: Billings
country: United States
facility: Billings Clinical Site
state: Montana
city: Reno
country: United States
facility: Reno Clinical Site
state: Nevada
city: Lebanon
country: United States
facility: Lebanon Clinical Site
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clinical Site
state: New Mexico
city: Great Neck
country: United States
facility: Great Neck Clinical Site
state: New York
city: Cary
country: United States
facility: Cary Clinical Site
state: North Carolina
city: Highpoint
country: United States
facility: Highpoint Clinical Site
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Clinical Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Winston-Salem Clinical Site
state: North Carolina
city: Akron
country: United States
facility: Akron Clinical Site
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Site
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Site
state: Ohio
city: Groveport
country: United States
facility: Groveport Clinical Site
state: Ohio
city: Mentor
country: United States
facility: Mentor Clinical Site
state: Ohio
city: Norman
country: United States
facility: Norman Clinical Site
state: Oklahoma
city: Landsdale
country: United States
facility: Lansdale Clinical Site
state: Pennsylvania
city: Greer
country: United States
facility: Greer Clinical Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Mt. Pleasant Clinical Site
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Clinical Site
state: Tennessee
city: Germantown
country: United States
facility: Germantown Clinical Site
state: Tennessee
city: Pasadena
country: United States
facility: Pasadena Clinical Site
state: Texas
city: Plano
country: United States
facility: Plano Clinial Site
state: Texas
city: San Antonio
country: United States
facility: San Antonio Clinical Site
state: Texas
city: Logan
country: United States
facility: Logan Clinical Site
state: Utah
city: Ogden
country: United States
facility: Ogden Clinical Site
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake City Clinical Site
state: Utah
city: Sandy
country: United States
facility: Sandy Clinical Site
state: Utah
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
citation: Whitehead WE, Duffy K, Sharpe J, Nabata T, Bruce M. Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Jan;45(1):14-26. doi: 10.1111/apt.13839. Epub 2016 Nov 7.