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)

March 17, 2016 updated by: Ono Pharma USA Inc

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)

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).

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Anniston, Alabama, United States, 36207
        • Anniston Clinical Site
    • Arizona
      • Goodyear, Arizona, United States, 85351
        • Goodyear Clinical Site
      • Tucson, Arizona, United States, 85712
        • Tucson Clinical Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72120
        • North Little Rock Clinical Site
    • California
      • Carlsbad, California, United States, 92008
        • Carlsbad Clinical Site
      • San Diego, California, United States, 92114
        • San Diego Clinical Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Boynton Beach Clinical Site
      • Clearwater, Florida, United States, 33756
        • Clearwater Clinical Site
      • Deland, Florida, United States, 32720
        • Deland Clinical Site
      • Hialeah, Florida, United States, 33012
        • Hialeah Clinical Site
      • Lauderdale Lakes, Florida, United States, 33319
        • Lauderdale Lakes Clinical Site
      • Orlando, Florida, United States, 32806
        • Orlando Clinical Site
      • Port Orange, Florida, United States, 32129
        • Port Orange Clinical Site
      • South Miami, Florida, United States, 33143
        • South Miami Clinical Site
      • St. Petersburg, Florida, United States, 33709
        • St. Petersburg Clinical Site
      • Tampa, Florida, United States, 33606
        • Tampa Clinical Site
      • West Palm, Florida, United States, 33409
        • West Palm Clinical Site
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Oak Lawn Clinical Site
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Wichita Clinical Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • New Orleans Clinical Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Chesterfield Clincial Site
    • Montana
      • Billings, Montana, United States, 59102
        • Billings Clinical Site
    • Nevada
      • Reno, Nevada, United States, 89511
        • Reno Clinical Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Lebanon Clinical Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Site
    • New York
      • Great Neck, New York, United States, 11023
        • Great Neck Clinical Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cary Clinical Site
      • Highpoint, North Carolina, United States, 27262
        • Highpoint Clinical Site
      • Raleigh, North Carolina, United States, 27612
        • Raleigh Clinical Site
      • Winston-Salem, North Carolina, United States, 27103
        • Winston-Salem Clinical Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Akron Clinical Site
      • Columbus, Ohio, United States, 43212
        • Columbus Clinical Site
      • Dayton, Ohio, United States, 45432
        • Dayton Clinical Site
      • Groveport, Ohio, United States, 43125
        • Groveport Clinical Site
      • Mentor, Ohio, United States, 44060
        • Mentor Clinical Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Norman Clinical Site
    • Pennsylvania
      • Landsdale, Pennsylvania, United States, 19446
        • Lansdale Clinical Site
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Greer Clinical Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Mt. Pleasant Clinical Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Chattanooga Clinical Site
      • Germantown, Tennessee, United States, 38138
        • Germantown Clinical Site
    • Texas
      • Pasadena, Texas, United States, 77505
        • Pasadena Clinical Site
      • Plano, Texas, United States, 75075
        • Plano Clinial Site
      • San Antonio, Texas, United States, 78229
        • San Antonio Clinical Site
    • Utah
      • Logan, Utah, United States, 84341
        • Logan Clinical Site
      • Ogden, Utah, United States, 84405
        • Ogden Clinical Site
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake City Clinical Site
      • Sandy, Utah, United States, 84094
        • Sandy Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm 1
ONO-2952 low dose every day for 4 weeks
Experimental: Experimental Arm 2
ONO-2952 high dose every day for 4 weeks
Placebo Comparator: Placebo Arm
ONO-2952 Matching Placebo every day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in IBS related symptoms and quality of life (QoL) by questionaire assessments
Time Frame: 4 weeks
4 weeks
Safety assessed through adverse events and clinical laboratory values
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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