Trial · NCT05175131

Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders

NCT05175131, Phase 3, Completed, Abbott; results first posted 2024-01-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders. Trials, record NCT05175131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05175131

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
NCT number: NCT05175131
Status: Completed
Phases: Phase 3
Enrollment: 465 participants, actual
Lead sponsor: Abbott
Conditions: Functional Bowel Disorder
Interventions: Mebeverine+Simethicone, Mebeverine, Simethicone
First posted: 2022-01-03
Last updated: 2025-09-16
Results first posted: 2024-01-03

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.	4 weeks	The baseline abdominal pain and bloating/flatulence intensity was determined as the average of the Numeric rating scale (NRS-11) daily assessment during 7 days before randomization. The Week 4 assessment was the average from last 7 days of the corresponding week. The scale is a horizontal 10 cm line with the numbers from 0 to 10 located on it, where 0 is "no pain/bloating", 10 is "most severe pain/bloating you can imagine".
Secondary	Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment	4 weeks	The baseline pain intensity was determined as the average of the Numeric rating scale (NRS-11) daily assessment during 7 days before randomization. The Week 4 assessment was the average from last 7 days of the corresponding week. The scale is a horizontal 10 cm line with the numbers from 0 to 10 located on it, where 0 is "no pain/bloating", 10 is "most severe pain/bloating you can imagine".
Secondary	Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment	4 weeks	The baseline bloating/flatulence intensity was determined as the average of the Numeric rating scale (NRS-11) daily assessment during 7 days before randomization. The Week 4 assessment was the average from last 7 days of the corresponding week. The scale is a horizontal 10 cm line with the numbers from 0 to 10 located on it, where 0 is "no pain/bloating", 10 is "most severe pain/bloating you can imagine".
Secondary	Change in Number of Days Per Week During Study Treatment Period When Drotaverine Was Taken.	4 weeks	The data from last week of screening and run-in period was used for baseline assessment of number of days of drotaverin intake. Week 1, Week 2, Week3 and Week 4 assessments were the data from the last 7 days of the corresponding week.
Secondary	Change in Quality of Life Evaluation Using IBSQOL Questionnaire Versus Baseline.	4 weeks	Patients were asked to evaluate the quality of life using the Irritable bowel syndrome quality of life (IBSQOL) questionnaire at baseline at Visit 2 (Week 0) and at the end of the study treatment at Visit 3 (Week 4). The individual responses to the 34 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.	4 weeks	465 subjects were allocated to treatment. 2 subjects had only a baseline assessment of the efficacy parameters and were excluded from the full analysis sample. Therefore, 463 subjects were included in the Full Analysis Sample (FAS)	score on a scale	MEAN
SECONDARY	Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment	4 weeks		score on a scale	MEAN
SECONDARY	Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment	4 weeks		score on a scale	MEAN
SECONDARY	Change in Number of Days Per Week During Study Treatment Period When Drotaverine Was Taken.	4 weeks		number of days	MEAN
SECONDARY	Change in Quality of Life Evaluation Using IBSQOL Questionnaire Versus Baseline.	4 weeks		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.	Mebeverine+Simethicone Combination	-7.23	Standard Deviation 3.42	score on a scale
Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.	Mebeverine	-6.48	Standard Deviation 3.48	score on a scale
Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.	Simethicone	-5.86	Standard Deviation 3.72	score on a scale
Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment	Mebeverine+Simethicone Combination	-3.59	Standard Deviation 1.77	score on a scale
Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment	Mebeverine	-3.19	Standard Deviation 1.80	score on a scale
Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment	Simethicone	-2.75	Standard Deviation 1.88	score on a scale
Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment	Mebeverine+Simethicone Combination	-3.65	Standard Deviation 1.82	score on a scale
Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment	Mebeverine	-3.29	Standard Deviation 1.91	score on a scale
Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment	Simethicone	-3.11	Standard Deviation 2.03	score on a scale
Change in Number of Days Per Week During Study Treatment Period When Drotaverine Was Taken.	Mebeverine+Simethicone Combination	-1.0	Standard Deviation 2.3	number of days

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mebeverine+Simethicone Combination	155
Overall Study	STARTED	Mebeverine	155
Overall Study	STARTED	Simethicone	155
Overall Study	COMPLETED	Mebeverine+Simethicone Combination	153
Overall Study	COMPLETED	Mebeverine	154
Overall Study	COMPLETED	Simethicone	152
Overall Study	NOT COMPLETED	Mebeverine+Simethicone Combination	2
Overall Study	NOT COMPLETED	Mebeverine	1
Overall Study	NOT COMPLETED	Simethicone	3

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Mebeverine+Simethicone Combination	23	155
other	Headache	Nervous system disorders	Mebeverine	18	155
other	Headache	Nervous system disorders	Simethicone	20	155
other	Nausea	Gastrointestinal disorders	Mebeverine+Simethicone Combination	11	155
other	Nausea	Gastrointestinal disorders	Mebeverine	7	155
other	Nausea	Gastrointestinal disorders	Simethicone	7	155
other	Asthenia	General disorders	Mebeverine+Simethicone Combination	5	155
other	Asthenia	General disorders	Mebeverine	11	155
other	Asthenia	General disorders	Simethicone	4	155
serious	Covid-19 Pneumonia	Infections and infestations	Mebeverine+Simethicone Combination	0	155

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mebeverine+Simethicone Combination	0	155
Total, all-cause mortality	Mebeverine	0	155
Total, all-cause mortality	Simethicone	0	155
Total, other adverse events	Mebeverine+Simethicone Combination	39	155
Total, other adverse events	Mebeverine	36	155
Total, other adverse events	Simethicone	31	155
Total, serious adverse events	Mebeverine+Simethicone Combination	0	155
Total, serious adverse events	Mebeverine	1	155
Total, serious adverse events	Simethicone	0	155

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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