Irritable Bowel SyndromePhase 4NCT01404923

Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)

A Phase 4 study testing anti spasmodic agents and alverine citrate, simeticone in people with Irritable Bowel Syndrome, run by Laboratoires Mayoly Spindler.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies: Strategy A = MeteoSpasmyl®, on-demand therapy Strategy B = standard of care chosen by the physician Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Irritable Bowel Syndrome
What is being tested?: anti spasmodic agents and alverine citrate, simeticone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 436 participants
Where: No sites listed yet
Study dates: Dec 2009to Oct 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

male or female ambulatory patients, aged >= 18 years
with IBS as defined by Rome III criteria for more than 1 year and less than 10 years
with a IBS-SSS between 175 and 400

Who cannot join

Acute diarrhea, bowel disorders due to an underlying cause
Patient treated with MeteoSpasmyl® within the past 6 months
Recent history of gastro intestinal surgery

About this study

Official title: Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome

The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:

Strategy A = MeteoSpasmyl®, on-demand therapy
Strategy B = standard of care chosen by the physician

Conditions: Irritable Bowel Syndrome
Being tested: anti spasmodic agents, alverine citrate, simeticone
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.

anti spasmodic agentsDrug
best standard of care prescriptions
alverine citrate, simeticoneDrug
on-demand therapy

Study groups in NCT01404923
Study group	Role	What they receive
meteospasmyl	Experimental	Not described Receives: Drug: alverine citrate, simeticone
standard of care	Active comparator	Not described Receives: Drug: anti spasmodic agents

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.
Measured: Baseline and 6 months
Percentage of Improvement of the Total IBSQoL Scores
Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
Measured: Baseline and 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Oct 2011

First posted28 Jul 2011 (estimated)
Study startDec 2009
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: None (open label)
Enrolment: 436 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01404923
Sponsor's protocol ID: FMTO901
Status last verified: Nov 2014
First submitted: 27 Jul 2011
Last updated: 4 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ducrotte P, Grimaud JC, Dapoigny M, Personnic S, O'Mahony V, Andro-Delestrain MC. On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014 Feb;68(2):245-54. doi: 10.1111/ijcp.12333. Epub 2013 Oct 21.
PubMed 24147869

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT01404923
Acronym / sponsor ID: FMTO901
Conditions: Irritable Bowel Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 436 participants (actual)
Lead sponsor: Laboratoires Mayoly SpindlerIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 28 Jul 2011 (estimated)
Results: Posted 4 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:

Strategy A = MeteoSpasmyl®, on-demand therapy
Strategy B = standard of care chosen by the physician

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
meteospasmyl	Experimental	Drug: alverine citrate, simeticone
standard of care	Active comparator	Drug: anti spasmodic agents

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

male or female ambulatory patients, aged >= 18 years
with IBS as defined by Rome III criteria for more than 1 year and less than 10 years
with a IBS-SSS between 175 and 400

Key exclusion criteria (3 listed)

Acute diarrhea, bowel disorders due to an underlying cause
Patient treated with MeteoSpasmyl® within the past 6 months
Recent history of gastro intestinal surgery

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
anti spasmodic agentsbest standard of care prescriptions	Drug	standard of care
alverine citrate, simeticoneon-demand therapy	Drug	meteospasmyl

Primary outcome

Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
Time frame: Baseline and 6 months
Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.
Percentage of Improvement of the Total IBSQoL Scores
Time frame: Baseline and 6 Months
Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage

Results and safety

Results posted to the registry on 4 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Meteospasmyl	222	199
Standard of Care	214	197

Primary outcome: Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score

Time frame: Baseline and 6 months. Mean (Standard Error). Unit: units on a scale

Measure	Meteospasmyl n = 173	Standard of Care n = 167
Value	13.8 (1.1)	8.4 (1.2)

Meteospasmyl vs Standard of Care: Mean Difference (Final Values): 5.4, p = 0.0008, ANCOVA

Population analysed: The efficacy population included all patients with a calculable IBSQoL score at baseline and at least one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.

Primary outcome: Percentage of Improvement of the Total IBSQoL Scores

Time frame: Baseline and 6 Months. Mean (Standard Deviation). Unit: % of improvement of IBSQoL total scores

Measure	Meteospasmyl n = 173	Standard of Care n = 167
Value	28.5 (49.1)	18.6 (37.2)

Population analysed: The efficacy population included all patients with a calculable IBSQoL score at baseline and at lesat one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.

Adverse events

Time frame: 6 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Meteospasmyl	5 of 222 (2.3%)	5 of 222 (2.3%)	Not reported
Standard of Care	1 of 210 (0.5%)	0 of 210 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24147869Ducrotte P, Grimaud JC, Dapoigny M, Personnic S, O'Mahony V, Andro-Delestrain MC. On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014 Feb;68(2):245-54. doi: 10.1111/ijcp.12333. Epub 2013 Oct 21.
Related InfoLink provided by the sponsor.

Related trials for Irritable Bowel Syndrome

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
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RecruitingPhase 2
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)
Irritable Bowel Syndrome, Diarrhea

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing anti spasmodic agents and alverine citrate, simeticone in people with Irritable Bowel Syndrome, run by Laboratoires Mayoly Spindler.

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 3 inclusion and 3 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

Yes. Results are posted in the registry (first posted 4 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01404923, which also lists 1 linked publication.

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 4 Nov 2014.