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

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT01678781
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 607

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (24)

Site reference ID/Investigator# 94523; 🇲🇽 Tampico, Mexico

Site reference ID/Investigaot# 94525; 🇲🇽 Guadalajara, Mexico

Site Reference ID/Investigator# 85297; 🇵🇱 Bialystok, 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, Poland

Site reference ID/Investigator# 94521; 🇨🇳 Guangzhou, China

Site reference ID/Investigator # 94518; 🇨🇳 Shanghai, China

Site reference ID/Investigator # 94515; 🇨🇳 Wuhan, China

Site reference ID/Investigator# 95475; 🇨🇳 Guangzhou City, China

Site reference ID/Investigator# 94519; 🇨🇳 Beijing, China

Site reference ID/Investigator# 95900; 🇪🇬 Cairo, Egypt

Site reference ID/Investigator# 95902; 🇪🇬 Giza, Egypt

Site reference ID/Investigator # 94516; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 95908; 🇪🇬 Alexandria, Egypt

Site reference ID/Investigator # 94517; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 85293; 🇵🇱 Katowice, Poland

Site reference ID/Investigator# 95901; 🇪🇬 El Sharkya, Egypt

Site Reference ID/Investigator# 85298; 🇵🇱 Bydgoszcz, Poland

Site Reference ID/Investigator# 95906; 🇪🇬 Port Said, Egypt

Site refernce ID/Investigator# 94527; 🇲🇽 Mexico City, Mexico

Site reference ID/Investigator# 85314; 🇵🇱 Bialystok, Poland

Site reference ID/Investigator# 95903; 🇪🇬 Giza, Egypt