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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT01678781

Collaborator

CHILTERN International GmbH (Other)

607

Enrollment

Locations

Duration (Months)

25.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

607 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
One patient group Patients suffering from irritable bowel syndrome

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Change in abdominal pain [From baseline up to the week 8 visit]
Change in bloating [From baseline up to the week 8 visit]
Change in feeling of abdominal distension [From baseline up to the week 8 visit]
Change in stool frequency [From baseline up to the week 8 visit]
Change in stool form [From baseline up to the week 8 visit]
Change in straining of evacuation [From baseline up to the week 8 visit]
Change in urgency of evacuation [From baseline up to the week 8 visit]
Change in feeling of incomplete evacuation [From baseline up to the week 8 visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site reference ID/Investigator# 94519	Beijing	China	100034
2	Site reference ID/Investigator# 95475	Guangzhou City	China	510515
3	Site reference ID/Investigator# 94521	Guangzhou	China	510080
4	Site reference ID/Investigator # 94518	Shanghai	China	200127
5	Site reference ID/Investigator # 94517	Shanghai	China	200433
6	Site reference ID/Investigator # 94516	Shanghai	China
7	Site reference ID/Investigator # 94515	Wuhan	China	430022
8	Site Reference ID/Investigator# 95908	Alexandria	Egypt
9	Site reference ID/Investigator# 95900	Cairo	Egypt
10	Site reference ID/Investigator# 95901	El Sharkya	Egypt
11	Site reference ID/Investigator# 95902	Giza	Egypt
12	Site reference ID/Investigator# 95903	Giza	Egypt
13	Site Reference ID/Investigator# 95906	Port Said	Egypt
14	Site reference ID/Investigaot# 94525	Guadalajara	Mexico	49000
15	Site refernce ID/Investigator# 94527	Mexico City	Mexico	54055
16	Site reference ID/Investigator# 94523	Tampico	Mexico	89190
17	Site reference ID/Investigator# 85314	Bialystok	Poland	15-270
18	Site Reference ID/Investigator# 85297	Bialystok	Poland	15-351
19	Site Reference ID/Investigator# 85298	Bydgoszcz	Poland	85-079
20	Site Reference ID/Investigator# 85293	Katowice	Poland	40-031
21	Site Reference ID/Investigator# 85296	Lodz	Poland	91-473
22	Site reference ID/Investigator# 85313	Olsztyn	Poland	10-501
23	Site Reference ID/Investigator# 85295	Poznan	Poland	60-193
24	Site Reference ID/Investigator# 85294	Poznan	Poland	60-539