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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01736423
First received: November 27, 2012
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Diarrhea-predominant Irritable Bowel Syndrome
Drug: YM060
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Monthly responder rate of global assessment of relief of overall IBS symptoms [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Monthly responder rate of stool form normalization [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Monthly responder rate of global assessment of relief of abdominal pain/discomfort [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Monthly responder rate of global assessment of improvement of abnormal bowel habits [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Change in weekly average of scores of severity of abdominal pain/discomfort [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Change in weekly average of scores of stool form [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Change in weekly average of stool frequency [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Rate of days without urgency [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Rate of days without feeling of incomplete bowel movement [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed through AEs and clinical laboratory values [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Female Patients with D-IBS Drug: YM060
oral
Other Name: Ramosetron

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01736423     History of Changes
Other Study ID Numbers: 060-CL-703
Study First Received: November 27, 2012
Last Updated: October 15, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on October 23, 2014