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NCT01678781 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01678781
Other study ID # P13-678
Secondary ID
Status Completed
Phase N/A
First received July 13, 2012
Last updated September 6, 2013
Start date July 2012
Est. completion date August 2013

Study information
Verified date September 2013
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsChina: Ethics CommitteeEgypt: Ministry of Health and PopulationMexico: Federal Commission for Sanitary Risks Protection
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 607
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Site reference ID/Investigator# 94519 Beijing
China Site reference ID/Investigator# 94521 Guangzhou
China Site reference ID/Investigator# 95475 Guangzhou City
China Site reference ID/Investigator # 94516 Shanghai
China Site reference ID/Investigator # 94517 Shanghai
China Site reference ID/Investigator # 94518 Shanghai
China Site reference ID/Investigator # 94515 Wuhan
Egypt Site Reference ID/Investigator# 95908 Alexandria
Egypt Site reference ID/Investigator# 95900 Cairo
Egypt Site reference ID/Investigator# 95901 El Sharkya
Egypt Site reference ID/Investigator# 95902 Giza
Egypt Site reference ID/Investigator# 95903 Giza
Egypt Site Reference ID/Investigator# 95906 Port Said
Mexico Site reference ID/Investigaot# 94525 Guadalajara
Mexico Site refernce ID/Investigator# 94527 Mexico City
Mexico Site reference ID/Investigator# 94523 Tampico
Poland Site Reference ID/Investigator# 85297 Bialystok
Poland Site reference ID/Investigator# 85314 Bialystok
Poland Site Reference ID/Investigator# 85298 Bydgoszcz
Poland Site Reference ID/Investigator# 85293 Katowice
Poland Site Reference ID/Investigator# 85296 Lodz
Poland Site reference ID/Investigator# 85313 Olsztyn
Poland Site Reference ID/Investigator# 85294 Poznan
Poland Site Reference ID/Investigator# 85295 Poznan

Sponsors (2)
Lead Sponsor Collaborator
Abbott CHILTERN International GmbH

Countries where clinical trial is conducted

China,  Egypt,  Mexico,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients From baseline up to the week 8 visit No
Secondary Change in abdominal pain From baseline up to the week 8 visit No
Secondary Change in bloating From baseline up to the week 8 visit No
Secondary Change in feeling of abdominal distension From baseline up to the week 8 visit No
Secondary Change in stool frequency From baseline up to the week 8 visit No
Secondary Change in stool form From baseline up to the week 8 visit No
Secondary Change in straining of evacuation From baseline up to the week 8 visit No
Secondary Change in urgency of evacuation From baseline up to the week 8 visit No
Secondary Change in feeling of incomplete evacuation From baseline up to the week 8 visit No
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