Irritable Bowel SyndromeNCT01678781
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 of Irritable Bowel Syndrome, run by Abbott at 24 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 607 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Jul 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic, community sample
Who may be able to join
- Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)
Who cannot join
- Pregnancy and lactation
- Specific contraindications to mebeverine hydrochloride or pinaverium bromide
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Poland8 sites
Site reference ID/Investigator# 85314
Bialystok, 15-270
Site Reference ID/Investigator# 85297
Bialystok, 15-351
Site Reference ID/Investigator# 85298
Bydgoszcz, 85-079
Site Reference ID/Investigator# 85293
Katowice, 40-031
Site Reference ID/Investigator# 85296
Lodz, 91-473
Site reference ID/Investigator# 85313
Olsztyn, 10-501
Site Reference ID/Investigator# 85295
Poznan, 60-193
Site Reference ID/Investigator# 85294
Poznan, 60-539
China7 sites
Site reference ID/Investigator# 94519
Beijing, 100034
Site reference ID/Investigator# 94521
Guangzhou, 510080
Site reference ID/Investigator# 95475
Guangzhou, 510515
Site reference ID/Investigator # 94518
Shanghai, 200127
Site reference ID/Investigator # 94517
Shanghai, 200433
Site reference ID/Investigator # 94516
Shanghai
Site reference ID/Investigator # 94515
Wuhan, 430022
Egypt6 sites
Site Reference ID/Investigator# 95908
Alexandria
Site reference ID/Investigator# 95900
Cairo
Site reference ID/Investigator# 95901
El Sharkya
Site reference ID/Investigator# 95902
Giza
Site reference ID/Investigator# 95903
Giza
Site Reference ID/Investigator# 95906
Port Said
Mexico3 sites
Site reference ID/Investigaot# 94525
Guadalajara, 49000
Site refernce ID/Investigator# 94527
Mexico City, 54055
Site reference ID/Investigator# 94523
Tampico, 89190
About this study
Official title: Open International Study on Quality of Life in IBS Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide
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
- Irritable Bowel Syndrome
- Keywords
- Abdominal pain, Diarrhea, Mebeverine hydrochloride, Constipation, Pinaverium bromide, Irritable bowel syndrome, Bloating, Quality of life
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| One patient group | Patients suffering from irritable bowel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients
Measured: From baseline up to the week 8 visit
Secondary outcomes (8)
Change in abdominal pain
Measured: From baseline up to the week 8 visit
Change in bloating
Measured: From baseline up to the week 8 visit
Change in feeling of abdominal distension
Measured: From baseline up to the week 8 visit
Change in stool frequency
Measured: From baseline up to the week 8 visit
Change in stool form
Measured: From baseline up to the week 8 visit
Change in straining of evacuation
Measured: From baseline up to the week 8 visit
Change in urgency of evacuation
Measured: From baseline up to the week 8 visit
Change in feeling of incomplete evacuation
Measured: From baseline up to the week 8 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CHILTERN International GmbH
- Responsible party
- Sponsor
- Investigators
- Guenter Krause, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678781
- Sponsor's protocol ID
- P13-678
- Status last verified
- Sep 2013
- First submitted
- 13 Jul 2012
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open International Study on Quality of Life in IBS Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide
- ClinicalTrials.gov ID
- NCT01678781
- Acronym / sponsor ID
- P13-678
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Abdominal pain, Diarrhea, Mebeverine hydrochloride, Constipation, Pinaverium bromide, Irritable bowel syndrome, Bloating, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- CHILTERN International GmbH
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One patient group | – | –Patients suffering from irritable bowel syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, community sample
Key inclusion criteria (1 listed)
- Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)
Key exclusion criteria (2 listed)
- Pregnancy and lactation
- Specific contraindications to mebeverine hydrochloride or pinaverium bromide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guenter Krause study director
Abbott
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Abbott at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland, China, Egypt, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.