Clinical trial NCT01678781: Open International Study on Quality of Life in Irritable Bowel Syndrome (IBS) Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide
Official title: Open International Study on Quality of Life in IBS Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: Abdominal pain
Diarrhea
Mebeverine hydrochloride
Constipation
Pinaverium bromide
Irritable bowel syndrome
Bloating
Quality of life
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: CHILTERN International GmbH
First posted: 2012-09-05
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, community sample

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients
timeFrame: From baseline up to the week 8 visit
Secondary outcomes:
measure: Change in abdominal pain
timeFrame: From baseline up to the week 8 visit
measure: Change in bloating
timeFrame: From baseline up to the week 8 visit
measure: Change in feeling of abdominal distension
timeFrame: From baseline up to the week 8 visit
measure: Change in stool frequency
timeFrame: From baseline up to the week 8 visit
measure: Change in stool form
timeFrame: From baseline up to the week 8 visit
measure: Change in straining of evacuation
timeFrame: From baseline up to the week 8 visit
measure: Change in urgency of evacuation
timeFrame: From baseline up to the week 8 visit
measure: Change in feeling of incomplete evacuation
timeFrame: From baseline up to the week 8 visit
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site reference ID/Investigator# 94519
city: Guangzhou City
country: China
facility: Site reference ID/Investigator# 95475
city: Guangzhou
country: China
facility: Site reference ID/Investigator# 94521
city: Shanghai
country: China
facility: Site reference ID/Investigator # 94518
city: Shanghai
country: China
facility: Site reference ID/Investigator # 94517
city: Shanghai
country: China
facility: Site reference ID/Investigator # 94516
city: Wuhan
country: China
facility: Site reference ID/Investigator # 94515
city: Alexandria
country: Egypt
facility: Site Reference ID/Investigator# 95908
city: Cairo
country: Egypt
facility: Site reference ID/Investigator# 95900
city: El Sharkya
country: Egypt
facility: Site reference ID/Investigator# 95901
city: Giza
country: Egypt
facility: Site reference ID/Investigator# 95902
city: Giza
country: Egypt
facility: Site reference ID/Investigator# 95903
city: Port Said
country: Egypt
facility: Site Reference ID/Investigator# 95906
city: Guadalajara
country: Mexico
facility: Site reference ID/Investigaot# 94525
city: Mexico City
country: Mexico
facility: Site refernce ID/Investigator# 94527
city: Tampico
country: Mexico
facility: Site reference ID/Investigator# 94523
city: Bialystok
country: Poland
facility: Site reference ID/Investigator# 85314
city: Bialystok
country: Poland
facility: Site Reference ID/Investigator# 85297
city: Bydgoszcz
country: Poland
facility: Site Reference ID/Investigator# 85298
city: Katowice
country: Poland
facility: Site Reference ID/Investigator# 85293
city: Lodz
country: Poland
facility: Site Reference ID/Investigator# 85296
city: Olsztyn
country: Poland
facility: Site reference ID/Investigator# 85313
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 85295
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 85294
Study officials:
affiliation: Abbott
name: Guenter Krause
role: STUDY_DIRECTOR
References: