Trial Outcomes & Findings for Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS) (NCT NCT01404923)

NCT ID: NCT01404923

Last Updated: 2014-11-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 436 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2014-11-04

Participant Flow

Participant milestones

Measure	Meteospasmyl alverine citrate, simeticone: on-demand therapy	Standard of Care anti spasmodic agents: best standard of care prescriptions
Overall Study STARTED	222	214
Overall Study COMPLETED	199	197
Overall Study NOT COMPLETED	23	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Meteospasmyl n=222 Participants alverine citrate, simeticone: on-demand therapy	Standard of Care n=214 Participants anti spasmodic agents: best standard of care prescriptions	Total n=436 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 14.9 • n=5 Participants	55.1 years STANDARD_DEVIATION 16.2 • n=7 Participants	54.4 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	160 Participants n=5 Participants	160 Participants n=7 Participants	320 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	54 Participants n=7 Participants	116 Participants n=5 Participants
Region of Enrollment France	222 participants n=5 Participants	214 participants n=7 Participants	436 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meteospasmyl n=173 Participants alverine citrate, simeticone: on-demand therapy	Standard of Care n=167 Participants anti spasmodic agents: best standard of care prescriptions
Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score	13.8 units on a scale Standard Error 1.1	8.4 units on a scale Standard Error 1.2

PRIMARY outcome

Timeframe: 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.

Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage

Outcome measures

Measure	Meteospasmyl n=173 Participants alverine citrate, simeticone: on-demand therapy	Standard of Care n=167 Participants anti spasmodic agents: best standard of care prescriptions
Percentage of Improvement of the Total IBSQoL Scores	28.5 % of improvement of IBSQoL total scores Standard Deviation 49.1	18.6 % of improvement of IBSQoL total scores Standard Deviation 37.2

Adverse Events

Meteospasmyl

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Standard of Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Meteospasmyl n=222 participants at risk alverine citrate, simeticone: on-demand therapy	Standard of Care n=210 participants at risk anti spasmodic agents: best standard of care prescriptions
Surgical and medical procedures pyloroplasty	0.45% 1/222 • Number of events 1 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)	0.00% 0/210 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)
Nervous system disorders transient ischaemic attack	0.45% 1/222 • Number of events 1 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)	0.00% 0/210 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)
Gastrointestinal disorders Sigmoiditis abcess intestinal	0.45% 1/222 • Number of events 1 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)	0.00% 0/210 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.45% 1/222 • Number of events 1 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)	0.00% 0/210 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)
Surgical and medical procedures Electrical cardioversion	0.45% 1/222 • Number of events 1 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)	0.00% 0/210 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/222 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)	0.48% 1/210 • Number of events 1 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)

Other adverse events

Measure	Meteospasmyl n=222 participants at risk alverine citrate, simeticone: on-demand therapy	Standard of Care n=210 participants at risk anti spasmodic agents: best standard of care prescriptions
Gastrointestinal disorders Nausea, diarrhea, heartburn	2.3% 5/222 • Number of events 5 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)	0.00% 0/210 • 6 months Four patients in standard of care group were excluded because no data available (Lost of follow up)

Additional Information

Clinical trials Manager

Laboratoires Mayoly Spindler

Phone: 33 134805555

Email: contact_essais_cliniques@mayoly-spindler.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60