CClinicalTrials.gg
Sign In
TerminatedNCT01887002RESTOREUpdated Feb 25, 2016

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)

A Phase 2 interventional study of ONO-2952 and Placebo comparator in Irritable Bowel Syndrome (IBS), sponsored by Ono Pharma USA Inc. Terminated at 4 sites in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Ono Pharma USA Inc · Phase 2, Interventional, and Treatment

Why this study was terminated
The study was terminated due to slow accrual of subjects.
Phase
Phase 2
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Irritable Bowel Syndrome (IBS)

Keywords

  • Irritable Bowel Syndrome
  • IBS
  • ONO-2952
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 39 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Ono Pharma USA Inc is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Experimental Arm 1

    ONO-2952 Active tablets, every day for 2 weeks

    Drug: ONO-2952

  • Placebo comparator
    Placebo Arm

    ONO-2952 Matching Placebo every day for 2 weeks

    Drug: Placebo comparator

Interventions

  • DrugONO-2952

    ONO-2952 Active tablets, every day for 2 weeks

  • DrugPlacebo comparator

    ONO-2952 Matching Placebo every day for 2 weeks

06

What researchers measure

Primary outcomes

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

    Time frame: 2 weeks

Secondary outcomes

  1. Safety assessed through adverse events and clinical laboratory values

    Time frame: 2 weeks

07

Study locations

4 sites
  • Boston Clinical Site
    Boston, Massachusetts 02215, United States
  • St. Louis Clinical Site
    St. Louis, Missouri 63110, United States
  • Chapel Hill Clinical Site
    Chapel Hill, North Carolina 27599, United States
  • Oklahoma City Clinical Site
    Oklahoma, Oklahoma 73160, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01887002
Lead sponsor
Ono Pharma USA Inc
Responsible party
Sponsor
First posted
Jun 26, 2013
Start date
Jun 2013
Primary completion
Jan 2015
Last update
Feb 25, 2016

Study contacts

Ono Pharma USA, Inc.
study director · Ono Pharmaceutical Co. Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Irritable Bowel Syndrome→

Other studies from this sponsor

Ono Pharma USA Inc

Start the discussion