Irritable Bowel Syndrome
Conditions
Brief 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
Interventions
DRUGanti spasmodic agents
best standard of care prescriptions
DRUGalverine citrate, simeticone
on-demand therapy
Sponsors
Laboratoires Mayoly Spindler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Acute diarrhea, bowel disorders due to an underlying cause * Patient treated with MeteoSpasmyl® within the past 6 months * Recent history of gastro intestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score | 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 | Baseline and 6 Months | Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meteospasmyl alverine citrate, simeticone: on-demand therapy | 222 |
| Standard of Care anti spasmodic agents: best standard of care prescriptions | 214 |
| Total | 436 |
Baseline characteristics
| Characteristic | Meteospasmyl | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 14.9 | 55.1 years STANDARD_DEVIATION 16.2 | 54.4 years STANDARD_DEVIATION 15.6 |
| Region of Enrollment France | 222 participants | 214 participants | 436 participants |
| Sex: Female, Male Female | 160 Participants | 160 Participants | 320 Participants |
| Sex: Female, Male Male | 62 Participants | 54 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 222 | 0 / 210 |
| serious Total, serious adverse events | 5 / 222 | 1 / 210 |
Outcome results
Primary
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.
Time frame: Baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meteospasmyl | Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score | 13.8 units on a scale | Standard Error 1.1 |
| Standard of Care | Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score | 8.4 units on a scale | Standard Error 1.2 |
p-value: 0.0008ANCOVA
Primary
Percentage of Improvement of the Total IBSQoL Scores
Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
Time frame: Baseline and 6 Months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meteospasmyl | Percentage of Improvement of the Total IBSQoL Scores | 28.5 % of improvement of IBSQoL total scores | Standard Deviation 49.1 |
| Standard of Care | Percentage of Improvement of the Total IBSQoL Scores | 18.6 % of improvement of IBSQoL total scores | Standard Deviation 37.2 |