Irritable Bowel SyndromePhase 4NCT00542295
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome
A Phase 4 study testing alverine citrate and simeticone in people with Irritable Bowel Syndrome, run by Laboratoires Mayoly Spindler at 18 sites in 2 countries.
Trial summary
To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- alverine citrate and simeticone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jul 2007to Sep 2008
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female ambulatory patients, aged 18-75 years
- with IBS as defined by Rome III criteria
Who cannot join
- Functional bowel disorder other than IBS,
- Underlying cause for symptomatology, which excludes IBS diagnosis,
- Gastro-intestinal cancer or significant gastro-intestinal surgical background,
- Any acute/uncontrolled systemic pathology
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Hungary12 sites
Study site
Budapest, 1083
Study site
Budapest, 1106
Study site
Budapest, 1125
Study site
Budapest, 1204
Study site
Debrecen, 4032
Study site
Győr, 9024
Study site
Gyula, 5700
Study site
Miskolc, 3501
Study site
Miskolc, 3529
Study site
Siofolk, 8600
Study site
Szeged, 6720
Study site
Székesfehérvár, 8000
Poland6 sites
Study site
Bydgoszcz, 85-168
Study site
Katowice, 40-752
Study site
Oława, 55-200
Study site
Szczecin, 71-252
Study site
Wroclaw, 50-556
Study site
Wroclaw, 51-149
About this study
Official title: Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial
To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design
- Conditions
- Irritable Bowel Syndrome
- Being tested
- alverine citrate and simeticone, placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alverine citrate and simeticoneDrug
Also called Meteospasmyl®
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: alverine citrate and simeticone |
| B | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject self assessment of abdominal pain/discomfort
Measured: Baseline and 4 weeks
Secondary outcomes (1)
IBS life impact, overall treatment assessment, concomitant factors
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionSep 2008
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Mayoly Spindler
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philippe Ducrotte, M.D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542295
- Sponsor's protocol ID
- IMTO601
- Status last verified
- Sep 2008
- First submitted
- 10 Oct 2007
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial
- ClinicalTrials.gov ID
- NCT00542295
- Acronym / sponsor ID
- IMTO601
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Laboratoires Mayoly SpindlerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Oct 2007 (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.
To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: alverine citrate and simeticone |
| B | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female ambulatory patients, aged 18-75 years
- with IBS as defined by Rome III criteria
Key exclusion criteria (4 listed)
- Functional bowel disorder other than IBS,
- Underlying cause for symptomatology, which excludes IBS diagnosis,
- Gastro-intestinal cancer or significant gastro-intestinal surgical background,
- Any acute/uncontrolled systemic pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alverine citrate and simeticoneAlso: Meteospasmyl® | Drug | A |
| placebo | Drug | B |
Primary outcome
Subject self assessment of abdominal pain/discomfort
Time frame: Baseline and 4 weeks
1 secondary outcome
IBS life impact, overall treatment assessment, concomitant factors
Time frame: Baseline and 4 weeks
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 1 Oct 2008.
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RecruitingObservational study
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
Philippe Ducrotte, M.D study chair
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alverine citrate and simeticone in people with Irritable Bowel Syndrome, run by Laboratoires Mayoly Spindler at 18 sites in 2 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 2 inclusion and 4 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 1 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Hungary, Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Subject self assessment of abdominal pain/discomfort (time frame: Baseline and 4 weeks). 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 1 Oct 2008.