CompletedNCT01678781Updated Sep 9, 2013

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

An observational study in Irritable Bowel Syndrome, sponsored by Abbott. Completed at 24 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-09.

Sponsored by Abbott · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 607
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Irritable Bowel Syndrome

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Keywords

Abdominal pain
Diarrhea
Mebeverine hydrochloride
Constipation
Pinaverium bromide
Irritable bowel syndrome
Bloating
Quality of life

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 607 is above the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Primary care clinic, community sample

Inclusion criteria

Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)

Exclusion criteria

Exclusion Criteria:

Pregnancy and lactation
Specific contraindications to mebeverine hydrochloride or pinaverium bromide

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 607 participants (actual)

Groups and cohorts

One patient group
Patients suffering from irritable bowel syndrome

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

24 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01678781
Lead sponsor: Abbott
Collaborators: CHILTERN International GmbH
Responsible party: Sponsor
First posted: Sep 5, 2012
Start date: Jul 2012
Primary completion: Aug 2013
Completion: Aug 2013
Last update: Sep 9, 2013

Study contacts

Guenter Krause

study director · Abbott

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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