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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01736423
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Diarrhea-predominant Irritable Bowel Syndrome Drug: YM060 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study Start Date : September 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Female Patients with D-IBS Drug: YM060
oral
Other Name: Ramosetron


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Safety assessed through AEs and clinical laboratory values [ Time Frame: up to 52 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Female patients who meet the following criteria:

  1. Patients satisfying the Rome III Diagnostic Criteria
  2. Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
  3. Patients who have abdominal pain or discomfort
  4. 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:

  1. Patients with a history of surgical resection of the stomach,gallbladder, small intestine or large intestine
  2. Patients with a history or current evidence of inflammatory bowel disease
  3. Patients with a history or current evidence of colitis ischemic
  4. Patients with concurrent infectious enteritis
  5. Patients with concurrent hyperthyroidism or hypothyroidism
  6. Patients with concurrent active peptic ulcer
  7. 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736423


Locations
Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01736423     History of Changes
Other Study ID Numbers: 060-CL-703
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Astellas Pharma Inc:
YM060
Ramosetron
long term study
Diarrhea-predominant Irritable Bowel Syndrome
Female

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action