A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
This study is currently recruiting participants.
Verified November 2012 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01736423
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736423
Contacts
| Contact: Clinical Development Administration Dept. | clinicaltrials_info@jp.astellas.com |
Locations
| Japan | |
| Recruiting | |
| Hokkaido, Japan | |
| Recruiting | |
| Kansai, Japan | |
| Recruiting | |
| Kantou, Japan | |
| Recruiting | |
| 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: | November 27, 2012 |
| 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 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 Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013