Trial record 13 of 32 for:    Open Studies | "Pain Perception"

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 is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Ono Pharmaceutical Co. Ltd
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01887002
First received: June 24, 2013
Last updated: April 16, 2014
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Primary Outcome Measures:
  • Change in pain intensity rating during rectal distention by using a numeric pain rating scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Primary Completion Date: July 2014 (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 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887002

Contacts
Contact: Sheetal Patel s-patel@ono-uk.co.uk

Locations
United States, Massachusetts
Boston Clinical Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
St. Louis Clinical Site Recruiting
St. Louis, Missouri, United States, 63110
United States, North Carolina
Chapel Hill Clinical Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
Oklahoma City Clinical Site Recruiting
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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01887002     History of Changes
Other Study ID Numbers: ONO-2952POU005
Study First Received: June 24, 2013
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
Irritable Bowel Syndrome
IBS
ONO-2952

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014