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)

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Ono Pharmaceuticals

Status and phase

Terminated
Phase 2

Conditions

Irritable Bowel Syndrome (IBS)

Treatments

Drug: ONO-2952
Drug: Placebo comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01887002
ONO-2952POU005

Details and patient eligibility

About

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

Enrollment

39 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

39 participants in 2 patient groups, including a placebo group

Experimental Arm 1
Experimental group
Description:
ONO-2952 Active tablets, every day for 2 weeks
Treatment:
Drug: ONO-2952
Placebo Arm
Placebo Comparator group
Description:
ONO-2952 Matching Placebo every day for 2 weeks
Treatment:
Drug: Placebo comparator

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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