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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) (RESTORE)

Primary Purpose

Irritable Bowel Syndrome (IBS)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ONO-2952
ONO-2952 Matching Placebo
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome (IBS) focused on measuring Irritable Bowel Syndrome, IBS, ONO-2952

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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:

      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

Sites / Locations

  • Anniston Clinical Site
  • Goodyear Clinical Site
  • Tucson Clinical Site
  • North Little Rock Clinical Site
  • Carlsbad Clinical Site
  • San Diego Clinical Site
  • Boynton Beach Clinical Site
  • Clearwater Clinical Site
  • Deland Clinical Site
  • Hialeah Clinical Site
  • Lauderdale Lakes Clinical Site
  • Orlando Clinical Site
  • Port Orange Clinical Site
  • South Miami Clinical Site
  • St. Petersburg Clinical Site
  • Tampa Clinical Site
  • West Palm Clinical Site
  • Oak Lawn Clinical Site
  • Wichita Clinical Site
  • New Orleans Clinical Site
  • Chesterfield Clincial Site
  • Billings Clinical Site
  • Reno Clinical Site
  • Lebanon Clinical Site
  • Albuquerque Clinical Site
  • Great Neck Clinical Site
  • Cary Clinical Site
  • Highpoint Clinical Site
  • Raleigh Clinical Site
  • Winston-Salem Clinical Site
  • Akron Clinical Site
  • Columbus Clinical Site
  • Dayton Clinical Site
  • Groveport Clinical Site
  • Mentor Clinical Site
  • Norman Clinical Site
  • Lansdale Clinical Site
  • Greer Clinical Site
  • Mt. Pleasant Clinical Site
  • Chattanooga Clinical Site
  • Germantown Clinical Site
  • Pasadena Clinical Site
  • Plano Clinial Site
  • San Antonio Clinical Site
  • Logan Clinical Site
  • Ogden Clinical Site
  • Salt Lake City Clinical Site
  • Sandy Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental Arm 1

Experimental Arm 2

Placebo Arm

Arm Description

ONO-2952 low dose every day for 4 weeks

ONO-2952 high dose every day for 4 weeks

ONO-2952 Matching Placebo every day for 4 weeks

Outcomes

Primary Outcome Measures

Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)

Secondary Outcome Measures

Change in IBS related symptoms and quality of life (QoL) by questionaire assessments
Safety assessed through adverse events and clinical laboratory values

Full Information

First Posted
April 24, 2013
Last Updated
March 17, 2016
Sponsor
Ono Pharma USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01844180
Brief Title
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)
Acronym
RESTORE
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
Keywords
Irritable Bowel Syndrome, IBS, ONO-2952

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm 1
Arm Type
Experimental
Arm Description
ONO-2952 low dose every day for 4 weeks
Arm Title
Experimental Arm 2
Arm Type
Experimental
Arm Description
ONO-2952 high dose every day for 4 weeks
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
ONO-2952 Matching Placebo every day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-2952
Intervention Type
Drug
Intervention Name(s)
ONO-2952 Matching Placebo
Primary Outcome Measure Information:
Title
Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in IBS related symptoms and quality of life (QoL) by questionaire assessments
Time Frame
4 weeks
Title
Safety assessed through adverse events and clinical laboratory values
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female 18-65 years of age (inclusive) 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharma USA, Inc.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Anniston Clinical Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Goodyear Clinical Site
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Tucson Clinical Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
North Little Rock Clinical Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
Facility Name
Carlsbad Clinical Site
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
San Diego Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Boynton Beach Clinical Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Clearwater Clinical Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Deland Clinical Site
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Hialeah Clinical Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Lauderdale Lakes Clinical Site
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Orlando Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Port Orange Clinical Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
South Miami Clinical Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
St. Petersburg Clinical Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Tampa Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
West Palm Clinical Site
City
West Palm
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Oak Lawn Clinical Site
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Wichita Clinical Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
New Orleans Clinical Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Chesterfield Clincial Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Billings Clinical Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Reno Clinical Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Lebanon Clinical Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albuquerque Clinical Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Great Neck Clinical Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Cary Clinical Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Highpoint Clinical Site
City
Highpoint
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Raleigh Clinical Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Winston-Salem Clinical Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Akron Clinical Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Columbus Clinical Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Dayton Clinical Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Groveport Clinical Site
City
Groveport
State/Province
Ohio
ZIP/Postal Code
43125
Country
United States
Facility Name
Mentor Clinical Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Norman Clinical Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Lansdale Clinical Site
City
Landsdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Greer Clinical Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Mt. Pleasant Clinical Site
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Chattanooga Clinical Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Germantown Clinical Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Pasadena Clinical Site
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Plano Clinial Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
San Antonio Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Logan Clinical Site
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Ogden Clinical Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Salt Lake City Clinical Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Sandy Clinical Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27910150
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.
Results Reference
derived

Learn more about this trial

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)

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