Trial Outcomes & Findings for Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders (NCT NCT05175131)
NCT ID: NCT05175131
Last Updated: 2025-09-16
Results Overview
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".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
465 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-09-16
Participant Flow
Participant milestones
| Measure |
Mebeverine+Simethicone Combination
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
155
|
155
|
155
|
|
Overall Study
COMPLETED
|
153
|
154
|
152
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
Baseline characteristics by cohort
| Measure |
Mebeverine+Simethicone Combination
n=155 Participants
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=155 Participants
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=155 Participants
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
151 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
449 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
315 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
150 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
460 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Russia
|
155 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
465 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 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)
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".
Outcome measures
| Measure |
Mebeverine+Simethicone Combination
n=154 Participants
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=155 Participants
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=154 Participants
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Change From Baseline of Sum of NRS-11 Abdominal Pain and Bloating/Flatulence Intensity Scores After 4 Weeks of Treatment.
|
-7.23 score on a scale
Standard Deviation 3.42
|
-6.48 score on a scale
Standard Deviation 3.48
|
-5.86 score on a scale
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: 4 weeksThe 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".
Outcome measures
| Measure |
Mebeverine+Simethicone Combination
n=154 Participants
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=155 Participants
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=154 Participants
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Change From Baseline of NRS-11 Pain Intensity After 4 Weeks of Treatment
|
-3.59 score on a scale
Standard Deviation 1.77
|
-3.19 score on a scale
Standard Deviation 1.80
|
-2.75 score on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: 4 weeksThe 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".
Outcome measures
| Measure |
Mebeverine+Simethicone Combination
n=154 Participants
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=155 Participants
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=154 Participants
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Change From Baseline of NRS-11 Bloating/Flatulence Intensity After 4 Weeks of Treatment
|
-3.65 score on a scale
Standard Deviation 1.82
|
-3.29 score on a scale
Standard Deviation 1.91
|
-3.11 score on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: 4 weeksThe 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.
Outcome measures
| Measure |
Mebeverine+Simethicone Combination
n=152 Participants
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=154 Participants
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=152 Participants
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Change in Number of Days Per Week During Study Treatment Period When Drotaverine Was Taken.
|
-1.0 number of days
Standard Deviation 2.3
|
-1.1 number of days
Standard Deviation 2.3
|
-0.6 number of days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 4 weeksPatients 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.
Outcome measures
| Measure |
Mebeverine+Simethicone Combination
n=154 Participants
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=155 Participants
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=154 Participants
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Change in Quality of Life Evaluation Using IBSQOL Questionnaire Versus Baseline.
|
-23.27 score on a scale
Standard Deviation 21.19
|
-19.57 score on a scale
Standard Deviation 19.77
|
-13.59 score on a scale
Standard Deviation 16.83
|
Adverse Events
Mebeverine+Simethicone Combination
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Mebeverine
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Simethicone
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mebeverine+Simethicone Combination
n=155 participants at risk
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=155 participants at risk
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=155 participants at risk
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
0.65%
1/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
0.00%
0/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
Other adverse events
| Measure |
Mebeverine+Simethicone Combination
n=155 participants at risk
three times a day per os
Mebeverine+Simethicone: fixed-dose combination, film-coated tablets, 135 mg + 80 mg
|
Mebeverine
n=155 participants at risk
three times a day per os
Mebeverine: Duspatalin®, coated tablets 135 mg
|
Simethicone
n=155 participants at risk
80 mg (2 capsules 40 mg) three times a day per os
Simethicone: Espumisan® capsules 40 mg
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
14.8%
23/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
11.6%
18/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
12.9%
20/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
|
Gastrointestinal disorders
Nausea
|
7.1%
11/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
4.5%
7/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
4.5%
7/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
|
General disorders
Asthenia
|
3.2%
5/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
7.1%
11/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
2.6%
4/155 • Period for AEs collection was from the first study drug dose to the end of 30 days follow-up post-therapy period. Duration of treatment was 28 days.
Any change to medical status, which occurred after study drug allocation at any dose in the specified study AE collection period were handled as an (S)AE. The post-therapy AE collection period was defined as 30 days after the subject's termination of study drug (collection of (S)AEs was passive in this period unless otherwise specified).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60