A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

NCT01870895 | Completed Phase 3

• 1 other identifier: 060-CL-702
• Study Type: interventional
• Target: 577
• Locations: 1 country
• Sites: 4

Brief Summary

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Keywords

YM060; Ramosetron; Diarrhea-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Monthly responder rate of global assessment of relief of overall IBS symptoms at final point

  Up to 12 weeks

• Monthly responder rate of stool form normalization at final point

  Up to 12 weeks

Secondary Outcomes (5)

• Monthly responder rate of global assessment of relief of abdominal pain/discomfort

  Up to 12 weeks

• Monthly responder rate of global assessment of improvement of abnormal bowel habits

  Up to 12 weeks

• Change in weekly average scores of severity of abdominal pain/discomfort

  Up to 12 weeks

• Change in weekly average scores of stool form

  Up to 12 weeks

• Safety assessment of YM060

  Up to 12 weeks

Study Arms (2)

YM060 group

EXPERIMENTAL

Drug: YM060

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

YM060 DRUG

oral

Also known as: ramosetron,, Irribow

YM060 group

Placebo DRUG

oral

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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

Kyushu, Japan

Location

Related Publications (1)

• Fukudo S, Kinoshita Y, Okumura T, Ida M, Akiho H, Nakashima Y, Nishida A, Haruma K. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016 Feb;150(2):358-66.e8. doi: 10.1053/j.gastro.2015.10.047. Epub 2015 Nov 6.

  PMID: 26551550 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Interventions

ramosetron

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 4, 2013
• First Posted: June 6, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

JP (4)