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

NCT01225237 | Completed Phase 4

• 1 other identifier: 060-CL-501
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

diarrhea; IBS; Colonic disease; YM060

Outcome Measures

Primary Outcomes (1)

• Responder rate of stool form normalization

  For 4 weeks

Secondary Outcomes (4)

• Responder rate of patients reported global assessment of relief of IBS symptoms

  For 4 weeks

• Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain

  For 4 weeks

• Responder rate of patients reported assessment of improvement of abnormal bowel habits

  For 4 weeks

• Safety assessed by the incidence of adverse events and abnormal values in labo-tests

  For 4 weeks

Study Arms (2)

ramosetron group

EXPERIMENTAL

Drug: Ramosetron

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramosetron DRUG

oral

Also known as: Irribow, YM060

ramosetron group

Placebo DRUG

oral

Placebo group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients meeting the Rome III Diagnostic Criteria
• Loose (mushy) or watery stools within the last 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (4)

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Related 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.

  PMID: 24315882 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea; Colonic Diseases

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

JP (4)