A Study to Evaluate Efficacy of Ramosetron on Diarrhea-pr... | NCT01225237

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

NCT01225237

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 15, 2014Estimated

Enrollment

296Actual

Phase

Phase 4

Conditions

Irritable Bowel Syndrome

Interventions

Ramosetron
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Oct 19, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

296Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ramosetron group	Experimental		Drug: Ramosetron
Placebo group	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramosetron	Drug	oral	ramosetron group	Irribow YM060

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Responder rate of stool form normalization		For 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24315882	Background	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.

Facility	Status	City	State	ZIP	Country	Contacts
		Hokkaido			Japan

ID	Term
D043183	Irritable Bowel Syndrome
D003967	Diarrhea
D003108	Colonic Diseases

ID	Term
D003109	Colonic Diseases, Functional
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases