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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm 1
ONO-2952 low dose every day for 4 weeks
Drug: ONO-2952
Experimental: Experimental Arm 2
ONO-2952 high dose every day for 4 weeks
Drug: ONO-2952
Placebo Comparator: Placebo Arm
ONO-2952 Matching Placebo every day for 4 weeks
Drug: ONO-2952 Matching Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ono Pharma USA Inc

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONO-2952POU004

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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