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The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meteospasmyl | Experimental |
| |
| standard of care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti spasmodic agents | Drug | best standard of care prescriptions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline and 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24147869 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Meteospasmyl | alverine citrate, simeticone: on-demand therapy |
| FG001 | Standard of Care | anti spasmodic agents: best standard of care prescriptions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Meteospasmyl | alverine citrate, simeticone: on-demand therapy |
| BG001 | Standard of Care | anti spasmodic agents: best standard of care prescriptions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 6 months |
|
6 months
Four patients in standard of care group were excluded because no data available (Lost of follow up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meteospasmyl | alverine citrate, simeticone: on-demand therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pyloroplasty | Surgical and medical procedures | Systematic Assessment | pre-existing disabling disorders of gastric emptying requiring surgery. Unexpected and not related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea, diarrhea, heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials Manager | Laboratoires Mayoly Spindler | 33 134805555 | contact_essais_cliniques@mayoly-spindler.fr |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C010846 | alverine |
| D012841 | Simethicone |
| ID | Term |
|---|---|
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
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| alverine citrate, simeticone |
| Drug |
on-demand therapy |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
anti spasmodic agents: best standard of care prescriptions |
|
|
|
| Primary | Percentage of Improvement of the Total IBSQoL Scores | Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage | 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. | Posted | Mean | Standard Deviation | % of improvement of IBSQoL total scores | Baseline and 6 Months |
|
|
|
| 5 |
| 222 |
| 5 |
| 222 |
| EG001 | Standard of Care | anti spasmodic agents: best standard of care prescriptions | 1 | 210 | 0 | 210 |
|
| transient ischaemic attack | Nervous system disorders | Systematic Assessment | Pre-existing hypertension and diabetes.Unexpected and not related to study drug |
|
| Sigmoiditis abcess intestinal | Gastrointestinal disorders | Systematic Assessment | sigmoid diverticulitis abscess. Unexpected, not related to study drug. |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Cancer of the cervix. Unexpected, not related to study drug |
|
| Electrical cardioversion | Surgical and medical procedures | Systematic Assessment | Medical history of hypertension, atrial fibrillation. Unexpected not related. |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Kidney tumor. Unexpected, not related. |
|
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| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |