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Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RESTORE)

This study has been terminated.
(The study was terminated due to slow accrual of subjects.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887002
First Posted: June 26, 2013
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
  Purpose
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D

Condition Intervention Phase
Irritable Bowel Syndrome (IBS) Drug: ONO-2952 Drug: Placebo comparator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RESTORE)

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):

Primary Outcome Measures:
  • Change in pain intensity rating during rectal distention by using a numeric pain rating scale [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Safety assessed through adverse events and clinical laboratory values [ Time Frame: 2 weeks ]

Enrollment: 39
Study Start Date: June 2013
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm 1
ONO-2952 Active tablets, every day for 2 weeks
Drug: ONO-2952
ONO-2952 Active tablets, every day for 2 weeks
Placebo Comparator: Placebo Arm
ONO-2952 Matching Placebo every day for 2 weeks
Drug: Placebo comparator
ONO-2952 Matching Placebo every day for 2 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:
    • improvement with defecation
    • onset associated with a change in frequency of stool/defecation
    • 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 Chron'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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887002


Locations
United States, Massachusetts
Boston Clinical Site
Boston, Massachusetts, United States, 02215
United States, Missouri
St. Louis Clinical Site
St. Louis, Missouri, United States, 63110
United States, North Carolina
Chapel Hill Clinical Site
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
Oklahoma City Clinical Site
Oklahoma, Oklahoma, United States, 73160
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01887002     History of Changes
Other Study ID Numbers: ONO-2952POU005
First Submitted: June 24, 2013
First Posted: June 26, 2013
Last Update Posted: February 25, 2016
Last Verified: January 2016

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
Irritable Bowel Syndrome
IBS
ONO-2952

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases