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

September 6, 2013 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

607

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • Site reference ID/Investigator# 94519
      • Guangzhou, China, 510080
        • Site reference ID/Investigator# 94521
      • Guangzhou City, China, 510515
        • Site reference ID/Investigator# 95475
      • Shanghai, China, 200127
        • Site reference ID/Investigator # 94518
      • Shanghai, China, 200433
        • Site reference ID/Investigator # 94517
      • Shanghai, China
        • Site reference ID/Investigator # 94516
      • Wuhan, China, 430022
        • Site reference ID/Investigator # 94515
  • Egypt
      • Alexandria, Egypt
        • Site Reference ID/Investigator# 95908
      • Cairo, Egypt
        • Site reference ID/Investigator# 95900
      • El Sharkya, Egypt
        • Site reference ID/Investigator# 95901
      • Giza, Egypt
        • Site reference ID/Investigator# 95902
      • Giza, Egypt
        • Site reference ID/Investigator# 95903
      • Port Said, Egypt
        • Site Reference ID/Investigator# 95906
  • Mexico
      • Guadalajara, Mexico, 49000
        • Site reference ID/Investigaot# 94525
      • Mexico City, Mexico, 54055
        • Site refernce ID/Investigator# 94527
      • Tampico, Mexico, 89190
        • Site reference ID/Investigator# 94523
  • Poland
      • Bialystok, Poland, 15-270
        • Site reference ID/Investigator# 85314
      • Bialystok, Poland, 15-351
        • Site Reference ID/Investigator# 85297
      • Bydgoszcz, Poland, 85-079
        • Site Reference ID/Investigator# 85298
      • Katowice, Poland, 40-031
        • Site Reference ID/Investigator# 85293
      • Lodz, Poland, 91-473
        • Site Reference ID/Investigator# 85296
      • Olsztyn, Poland, 10-501
        • Site reference ID/Investigator# 85313
      • Poznan, Poland, 60-193
        • Site Reference ID/Investigator# 85295
      • Poznan, Poland, 60-539
        • Site Reference ID/Investigator# 85294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic, community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
One patient group
Patients suffering from irritable bowel syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in abdominal pain
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit
Change in bloating
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit
Change in feeling of abdominal distension
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit
Change in stool frequency
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit
Change in stool form
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit
Change in straining of evacuation
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit
Change in urgency of evacuation
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit
Change in feeling of incomplete evacuation
Time Frame: From baseline up to the week 8 visit
From baseline up to the week 8 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

CHILTERN International GmbH

Investigators

  • Study Director: Guenter Krause, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

September 6, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P13-678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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