A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

Irritable Bowel Syndrome Clinical Trial

Official title:

Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - Double-blind, Parallel-group Comparative Study in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225237
• Other study ID #: 060-CL-501
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2010
• Last updated: October 14, 2014
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients meeting the Rome III Diagnostic Criteria

• Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

• Patients with a history of surgical resection of the stomach, small intestine or large intestine

• Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)

• Patients with a history or current diagnosis of colitis ischemic

• Patients with a current diagnosis of enteritis infectious

• Patients with a current diagnosis of hyperthyroidism or hypothyroidism

• Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study

• Patients with a history or current diagnosis of malignant tumor

• Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Ramosetron
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Fukudo S, Ida M, Akiho H, Nakashima Y, Matsueda K. Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea. Clin Gastroenterol Hepatol. 2014 Jun;12(6):953-9.e4. doi: 10.1016/j.cgh.2013.11.024. Epub 2013 Dec 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate of stool form normalization		For 4 weeks	No
Secondary	Responder rate of patients reported global assessment of relief of IBS symptoms		For 4 weeks	No
Secondary	Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain		For 4 weeks	No
Secondary	Responder rate of patients reported assessment of improvement of abnormal bowel habits		For 4 weeks	No
Secondary	Safety assessed by the incidence of adverse events and abnormal values in labo-tests		For 4 weeks	No

External Links

•   Link to Results on JAPIC - enter 140634 in the JapicCTI-RNo. field (Japanese record)