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)

NCT01887002 | Terminated Phase 2

• 1 other identifier: ONO-2952POU005
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

Brief Summary

The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome; IBS; ONO-2952

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity rating during rectal distention by using a numeric pain rating scale

  2 weeks

Secondary Outcomes (1)

• Safety assessed through adverse events and clinical laboratory values

  2 weeks

Study Arms (2)

Experimental Arm 1

EXPERIMENTAL

ONO-2952 Active tablets, every day for 2 weeks

Drug: ONO-2952

Placebo Arm

PLACEBO COMPARATOR

ONO-2952 Matching Placebo every day for 2 weeks

Drug: Placebo comparator

Interventions

ONO-2952 DRUG

ONO-2952 Active tablets, every day for 2 weeks

Experimental Arm 1

Placebo comparator DRUG

ONO-2952 Matching Placebo every day for 2 weeks

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ono Pharma USA Inc: lead

Study Sites (4)

Boston Clinical Site

Boston, Massachusetts, 02215, United States

Location

St. Louis Clinical Site

St Louis, Missouri, 63110, United States

Location

Chapel Hill Clinical Site

Chapel Hill, North Carolina, 27599, United States

Location

Oklahoma City Clinical Site

Oklahoma City, Oklahoma, 73160, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

ONO-2952

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ono Pharma USA, Inc.

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2016-01

Locations

US (4)