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Completed

NCT Number: NCT01844180

A Phase 2, Multi-center Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Anniston Clinical Site, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Crohn'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

Treatment and study plan

ONO-2952

Drug

ONO-2952 Matching Placebo

Drug

Primary outcomes

  1. Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)

    Time frame: 4 weeks

Secondary outcomes

  1. Change in IBS related symptoms and quality of life (QoL) by questionaire assessments

    Time frame: 4 weeks

  2. Safety assessed through adverse events and clinical laboratory values

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Acronym: RESTORE

Important dates

Study start
2013
Primary completion
2014
First posted
May 1, 2013
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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