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Completed

NCT Number: NCT01736423

A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).

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Key information

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Age range

20 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hokkaido, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female patients who meet the following criteria:

  • Patients satisfying the Rome III Diagnostic Criteria
  • Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
  • Patients who have abdominal pain or discomfort
  • Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion criteria

Patients who meet any of the following criteria:

  • Patients with a history of surgical resection of the stomach,gallbladder, small intestine or large intestine
  • Patients with a history or current evidence of inflammatory bowel disease
  • Patients with a history or current evidence of colitis ischemic
  • Patients with concurrent infectious enteritis
  • Patients with concurrent hyperthyroidism or hypothyroidism
  • Patients with concurrent active peptic ulcer
  • Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort

Treatment and study plan

YM060

Drug

oral

Other names: Ramosetron

Primary outcomes

  1. Monthly responder rate of global assessment of relief of overall IBS symptoms

    Time frame: up to 52 weeks

  2. Monthly responder rate of stool form normalization

    Time frame: up to 52 weeks

  3. Monthly responder rate of global assessment of relief of abdominal pain/discomfort

    Time frame: up to 52 weeks

  4. Monthly responder rate of global assessment of improvement of abnormal bowel habits

    Time frame: up to 52 weeks

  5. Change in weekly average of scores of severity of abdominal pain/discomfort

    Time frame: up to 52 weeks

  6. Change in weekly average of scores of stool form

    Time frame: up to 52 weeks

  7. Change in weekly average of stool frequency

    Time frame: up to 52 weeks

  8. Rate of days without urgency

    Time frame: up to 52 weeks

  9. Rate of days without feeling of incomplete bowel movement

    Time frame: up to 52 weeks

  10. Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales

    Time frame: 4, 8, 12, 28 and 52 weeks

Secondary outcomes

  1. Safety assessed through AEs and clinical laboratory values

    Time frame: up to 52 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2012
Registry last updated
Oct 12, 2015

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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