A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

NCT ID: NCT00918411

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Ramosetron group

oral

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

oral

Placebo group

oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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Ramosetron

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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Irribow YM060

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients having hyperthyroidism or hypothyroidism
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kantou, , Japan

Site Status

Kyusyu, , Japan

Site Status

Countries

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Japan

References

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Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 16;11:8. doi: 10.1186/s13030-017-0093-9. eCollection 2017.

Reference Type DERIVED
PMID: 28331539 (View on PubMed)

Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 11;11:7. doi: 10.1186/s13030-017-0092-x. eCollection 2017.

Reference Type DERIVED
PMID: 28293280 (View on PubMed)

Related Links

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https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=060-CL-500

Link to results on Astellas Clinical Study Results Web site

Other Identifiers

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060-CL-500

Identifier Type: -

Identifier Source: org_study_id

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