Open International Study on Quality of Life in Irritable Bowel Syndrome (IBS) Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide

NCT ID: NCT01678781

Last Updated: 2013-09-09

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

Total Enrollment

607 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-08-31

Brief Summary

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A study to evaluate, by country and overall, the changes from baseline of the irritable bowel syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with Duspatalin® or Dicetel® in IBS patients.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Keywords

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Abdominal pain Diarrhea Mebeverine hydrochloride Constipation Pinaverium bromide Irritable bowel syndrome Bloating Quality of life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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One patient group

Patients suffering from irritable bowel syndrome

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)

Exclusion Criteria

* Pregnancy and lactation
* Specific contraindications to mebeverine hydrochloride or pinaverium bromide
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHILTERN International GmbH

UNKNOWN

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guenter Krause

Role: STUDY_DIRECTOR

Abbott

Locations

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Site reference ID/Investigator# 94519

Beijing, , China

Site Status

Site reference ID/Investigator# 94521

Guangzhou, , China

Site Status

Site reference ID/Investigator# 95475

Guangzhou, , China

Site Status

Site reference ID/Investigator # 94518

Shanghai, , China

Site Status

Site reference ID/Investigator # 94517

Shanghai, , China

Site Status

Site reference ID/Investigator # 94516

Shanghai, , China

Site Status

Site reference ID/Investigator # 94515

Wuhan, , China

Site Status

Site Reference ID/Investigator# 95908

Alexandria, , Egypt

Site Status

Site reference ID/Investigator# 95900

Cairo, , Egypt

Site Status

Site reference ID/Investigator# 95901

El Sharkya, , Egypt

Site Status

Site reference ID/Investigator# 95902

Giza, , Egypt

Site Status

Site reference ID/Investigator# 95903

Giza, , Egypt

Site Status

Site Reference ID/Investigator# 95906

Port Said, , Egypt

Site Status

Site reference ID/Investigaot# 94525

Guadalajara, , Mexico

Site Status

Site refernce ID/Investigator# 94527

Mexico City, , Mexico

Site Status

Site reference ID/Investigator# 94523

Tampico, , Mexico

Site Status

Site reference ID/Investigator# 85314

Bialystok, , Poland

Site Status

Site Reference ID/Investigator# 85297

Bialystok, , Poland

Site Status

Site Reference ID/Investigator# 85298

Bydgoszcz, , Poland

Site Status

Site Reference ID/Investigator# 85293

Katowice, , Poland

Site Status

Site Reference ID/Investigator# 85296

Lodz, , Poland

Site Status

Site reference ID/Investigator# 85313

Olsztyn, , Poland

Site Status

Site Reference ID/Investigator# 85295

Poznan, , Poland

Site Status

Site Reference ID/Investigator# 85294

Poznan, , Poland

Site Status

Countries

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China Egypt Mexico Poland

Other Identifiers

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P13-678

Identifier Type: -

Identifier Source: org_study_id