Trial Outcomes & Findings for Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults (NCT NCT02704091)
NCT ID: NCT02704091
Last Updated: 2020-11-05
Results Overview
Time to recovery was defined as the time from the first study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a non-watery stool, recorded in the DEB. Results are presented as median time to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
858 participants
Primary outcome timeframe
From randomisation (Day 1) up to Day 9
Results posted on
2020-11-05
Participant Flow
The study enrolled adult participants with a recent episode of acute diarrhoea presumed of infectious origin, defined as the passage of 3 or more unformed (loose or watery) stools per day without alarm symptoms within the first 48 hours. Participants were randomised at 62 study centres in Algeria, Czech Republic, Egypt, Lebanon, Poland and Tunisia.
858 participants were randomised, of which 853 were included in the analysis and 5 were excluded due to invalid consent. Only participants included in the analysis are presented in the participant flow. Participants received a diary evaluation booklet (DEB) to record each stool plus consistency on a daily basis from inclusion until end of study.
Participant milestones
| Measure |
Diosmectite
Participants received diosmectite as 2 sachets, three times a day (TID) (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Overall Study
STARTED
|
430
|
423
|
|
Overall Study
COMPLETED
|
402
|
400
|
|
Overall Study
NOT COMPLETED
|
28
|
23
|
Reasons for withdrawal
| Measure |
Diosmectite
Participants received diosmectite as 2 sachets, three times a day (TID) (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Consent withdrawn
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
13
|
5
|
|
Overall Study
Other
|
2
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Diosmectite
n=430 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=423 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Total Title
n=853 Participants
|
|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 14.5 • n=430 Participants
|
38.6 years
STANDARD_DEVIATION 14.2 • n=423 Participants
|
39.1 years
STANDARD_DEVIATION 14.4 • n=853 Participants
|
|
Sex: Female, Male
Female
|
232 Participants
n=430 Participants
|
241 Participants
n=423 Participants
|
473 Participants
n=853 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=430 Participants
|
182 Participants
n=423 Participants
|
380 Participants
n=853 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (except for those excluded from the analysis), analysed according to the arm to which they were randomised.
Time to recovery was defined as the time from the first study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a non-watery stool, recorded in the DEB. Results are presented as median time to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Outcome measures
| Measure |
Diosmectite
n=430 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=423 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Time to Recovery
|
66.0 Hours
Interval 53.7 to 71.0
|
68.6 Hours
Interval 57.5 to 77.8
|
SECONDARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available were included in the analysis.
The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of recovery (i.e. first formed stool followed by a non-watery stool) was recorded in the DEB. Results are presented as median time from diarrhoea onset to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Outcome measures
| Measure |
Diosmectite
n=429 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=423 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Time From Diarrhoea Onset to Recovery
|
91.0 Hours
Interval 82.5 to 107.0
|
92.2 Hours
Interval 84.2 to 102.8
|
SECONDARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available were included in the analysis.
The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of first formed stool was recorded in the DEB. Results are presented as median time from diarrhoea onset to first formed stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no formed stool or ending the study with no formed stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Outcome measures
| Measure |
Diosmectite
n=429 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=423 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Time From Diarrhoea Onset to First Formed Stool
|
84.3 Hours
Interval 77.5 to 94.2
|
84.6 Hours
Interval 79.8 to 91.0
|
SECONDARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (except for those excluded from the analysis), analysed according to the arm to which they were randomised.
The event of first study treatment intake was recorded in the eCRF and the event of last watery stool was recorded in the DEB. Results are presented as median time from first study treatment intake to last watery stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no watery stool or ending the study with no watery stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).
Outcome measures
| Measure |
Diosmectite
n=430 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=423 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Time From the First Study Treatment Intake to the Last Watery Stool
|
56.2 Hours
Interval 44.6 to 66.2
|
60.0 Hours
Interval 52.8 to 68.8
|
SECONDARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.
Number of stools, per 12-hour period, was recorded in the DEB.
Outcome measures
| Measure |
Diosmectite
n=413 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=412 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Number of Stools, Per 12-Hour Period
0 - 12 hours
|
3.0 Stools
Interval 0.0 to 11.0
|
3.0 Stools
Interval 0.0 to 14.0
|
|
Number of Stools, Per 12-Hour Period
12 - 24 hours
|
2.0 Stools
Interval 0.0 to 7.0
|
2.0 Stools
Interval 0.0 to 7.0
|
|
Number of Stools, Per 12-Hour Period
24 - 36 hours
|
1.0 Stools
Interval 0.0 to 8.0
|
2.0 Stools
Interval 0.0 to 19.0
|
|
Number of Stools, Per 12-Hour Period
36 - 48 hours
|
1.0 Stools
Interval 0.0 to 7.0
|
1.0 Stools
Interval 0.0 to 6.0
|
|
Number of Stools, Per 12-Hour Period
48 - 60 hours
|
1.0 Stools
Interval 0.0 to 7.0
|
1.0 Stools
Interval 0.0 to 9.0
|
|
Number of Stools, Per 12-Hour Period
60 - 72 hours
|
1.0 Stools
Interval 0.0 to 6.0
|
1.0 Stools
Interval 0.0 to 7.0
|
|
Number of Stools, Per 12-Hour Period
72 - 84 hours
|
1.0 Stools
Interval 0.0 to 12.0
|
1.0 Stools
Interval 0.0 to 7.0
|
|
Number of Stools, Per 12-Hour Period
84 - 96 hours
|
1.0 Stools
Interval 0.0 to 6.0
|
1.0 Stools
Interval 0.0 to 7.0
|
|
Number of Stools, Per 12-Hour Period
96 - 108 hours
|
1.0 Stools
Interval 0.0 to 5.0
|
1.0 Stools
Interval 0.0 to 7.0
|
|
Number of Stools, Per 12-Hour Period
108 - 120 hours
|
1.0 Stools
Interval 0.0 to 5.0
|
1.0 Stools
Interval 0.0 to 6.0
|
|
Number of Stools, Per 12-Hour Period
120 - 132 hours
|
1.0 Stools
Interval 0.0 to 4.0
|
1.0 Stools
Interval 0.0 to 6.0
|
|
Number of Stools, Per 12-Hour Period
132 - 144 hours
|
1.0 Stools
Interval 0.0 to 6.0
|
1.0 Stools
Interval 0.0 to 4.0
|
|
Number of Stools, Per 12-Hour Period
144 - 156 hours
|
1.0 Stools
Interval 0.0 to 4.0
|
1.0 Stools
Interval 0.0 to 6.0
|
|
Number of Stools, Per 12-Hour Period
156 - 168 hours
|
1.0 Stools
Interval 0.0 to 4.0
|
1.0 Stools
Interval 0.0 to 5.0
|
|
Number of Stools, Per 12-Hour Period
168 - 180 hours
|
1.0 Stools
Interval 0.0 to 5.0
|
1.0 Stools
Interval 0.0 to 4.0
|
|
Number of Stools, Per 12-Hour Period
180 - 192 hours
|
1.0 Stools
Interval 0.0 to 5.0
|
1.0 Stools
Interval 0.0 to 5.0
|
|
Number of Stools, Per 12-Hour Period
192 - 204 hours
|
1.0 Stools
Interval 1.0 to 4.0
|
1.0 Stools
Interval 0.0 to 4.0
|
|
Number of Stools, Per 12-Hour Period
204 - 216 hours
|
—
|
1.0 Stools
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.
Number of watery stools, per 12-hour period, was recorded in the DEB.
Outcome measures
| Measure |
Diosmectite
n=413 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=412 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Number of Watery Stools, Per 12-Hour Period
0 - 12 hours
|
3.0 Stools
Interval 0.0 to 11.0
|
3.0 Stools
Interval 0.0 to 14.0
|
|
Number of Watery Stools, Per 12-Hour Period
12 - 24 hours
|
1.0 Stools
Interval 0.0 to 7.0
|
1.0 Stools
Interval 0.0 to 7.0
|
|
Number of Watery Stools, Per 12-Hour Period
24 - 36 hours
|
0.0 Stools
Interval 0.0 to 8.0
|
1.0 Stools
Interval 0.0 to 19.0
|
|
Number of Watery Stools, Per 12-Hour Period
48 - 60 hours
|
0.0 Stools
Interval 0.0 to 7.0
|
0.0 Stools
Interval 0.0 to 9.0
|
|
Number of Watery Stools, Per 12-Hour Period
60 - 72 hours
|
0.0 Stools
Interval 0.0 to 6.0
|
0.0 Stools
Interval 0.0 to 7.0
|
|
Number of Watery Stools, Per 12-Hour Period
72 - 84 hours
|
0.0 Stools
Interval 0.0 to 10.0
|
0.0 Stools
Interval 0.0 to 7.0
|
|
Number of Watery Stools, Per 12-Hour Period
84 - 96 hours
|
0.0 Stools
Interval 0.0 to 6.0
|
0.0 Stools
Interval 0.0 to 7.0
|
|
Number of Watery Stools, Per 12-Hour Period
96 - 108 hours
|
0.0 Stools
Interval 0.0 to 5.0
|
0.0 Stools
Interval 0.0 to 7.0
|
|
Number of Watery Stools, Per 12-Hour Period
108 - 120 hours
|
0.0 Stools
Interval 0.0 to 5.0
|
0.0 Stools
Interval 0.0 to 6.0
|
|
Number of Watery Stools, Per 12-Hour Period
168 - 180 hours
|
0.0 Stools
Interval 0.0 to 5.0
|
0.0 Stools
Interval 0.0 to 4.0
|
|
Number of Watery Stools, Per 12-Hour Period
180 - 192 hours
|
0.0 Stools
Interval 0.0 to 5.0
|
0.0 Stools
Interval 0.0 to 5.0
|
|
Number of Watery Stools, Per 12-Hour Period
192 - 204 hours
|
0.0 Stools
Interval 0.0 to 4.0
|
0.0 Stools
Interval 0.0 to 3.0
|
|
Number of Watery Stools, Per 12-Hour Period
36 - 48 hours
|
0.0 Stools
Interval 0.0 to 7.0
|
0.0 Stools
Interval 0.0 to 6.0
|
|
Number of Watery Stools, Per 12-Hour Period
120 - 132 hours
|
0.0 Stools
Interval 0.0 to 4.0
|
0.0 Stools
Interval 0.0 to 5.0
|
|
Number of Watery Stools, Per 12-Hour Period
132 - 144 hours
|
0.0 Stools
Interval 0.0 to 6.0
|
0.0 Stools
Interval 0.0 to 4.0
|
|
Number of Watery Stools, Per 12-Hour Period
144 - 156 hours
|
0.0 Stools
Interval 0.0 to 3.0
|
0.0 Stools
Interval 0.0 to 5.0
|
|
Number of Watery Stools, Per 12-Hour Period
156 - 168 hours
|
0.0 Stools
Interval 0.0 to 4.0
|
0.0 Stools
Interval 0.0 to 5.0
|
|
Number of Watery Stools, Per 12-Hour Period
204 - 216 hours
|
—
|
0.0 Stools
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.
Percentage of participants with associated symptoms (at least 1 symptom of nausea, vomiting, abdominal pain or anal irritation) per 12-hour period is presented. Nausea, vomiting, abdominal pain and anal irritation were recorded in the DEB.
Outcome measures
| Measure |
Diosmectite
n=430 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=423 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
12 - 24 hours
|
67.1 Percentage of participants
|
64.6 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
24 - 36 hours
|
56.2 Percentage of participants
|
54.2 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
36 - 48 hours
|
44.8 Percentage of participants
|
45.6 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
48 - 60 hours
|
34.9 Percentage of participants
|
35.4 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
60 - 72 hours
|
28.7 Percentage of participants
|
28.8 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
108 - 120 hours
|
18.6 Percentage of participants
|
24.9 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
120 - 132 hours
|
18.4 Percentage of participants
|
27.9 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
132 - 144 hours
|
12.6 Percentage of participants
|
21.4 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
144 - 156 hours
|
10.5 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
156 - 168 hours
|
8.5 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
168 - 180 hours
|
8.6 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
0 - 12 hours
|
76.3 Percentage of participants
|
76.4 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
72 - 84 hours
|
24.3 Percentage of participants
|
22.0 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
84 - 96 hours
|
21.6 Percentage of participants
|
20.6 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
96 - 108 hours
|
20.6 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
180 - 192 hours
|
8.2 Percentage of participants
|
9.8 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
192 - 204 hours
|
9.7 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Associated Symptoms, Per 12-Hour Period
204 - 216 hours
|
5.9 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation (Day 1) up to Day 9Population: The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.
Abdominal pain intensity per 12-hour period was recorded in the DEB. Abdominal pain intensity was rated with a 5-point ordinal scale: 0 = absent, 1= mild, 2 =moderate, 3 = severe, 4= very severe. Higher scores indicate a worse outcome. The median abdominal pain intensity score for each 12-hour period is presented.
Outcome measures
| Measure |
Diosmectite
n=430 Participants
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=423 Participants
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
156 - 168 hours
|
0.0 Scores on a scale
Interval 0.0 to 3.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
168 - 180 hours
|
0.0 Scores on a scale
Interval 0.0 to 3.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
180 - 192 hours
|
0.0 Scores on a scale
Interval 0.0 to 2.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
12 - 24 hours
|
1.0 Scores on a scale
Interval 0.0 to 4.0
|
1.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
24 - 36 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
96 - 108 hours
|
0.0 Scores on a scale
Interval 0.0 to 3.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
108 - 120 hours
|
0.0 Scores on a scale
Interval 0.0 to 3.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
120 - 132 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
144 - 156 hours
|
0.0 Scores on a scale
Interval 0.0 to 3.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
192 - 204 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
204 - 216 hours
|
0.0 Scores on a scale
Interval 0.0 to 1.0
|
0.0 Scores on a scale
Interval 0.0 to 0.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
0 - 12 hours
|
1.0 Scores on a scale
Interval 0.0 to 4.0
|
1.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
36 - 48 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
48 - 60 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
60 - 72 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
72 - 84 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
84 - 96 hours
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
|
Abdominal Pain Intensity Scores, Per 12-Hour Period
132 - 144 hours
|
0.0 Scores on a scale
Interval 0.0 to 2.0
|
0.0 Scores on a scale
Interval 0.0 to 4.0
|
Adverse Events
Diosmectite
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diosmectite
n=430 participants at risk
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=421 participants at risk
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
Other adverse events
| Measure |
Diosmectite
n=430 participants at risk
Participants received diosmectite as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
Placebo
n=421 participants at risk
Participants received matching placebo as 2 sachets, TID (2 sachets in the morning, 2 sachets at mid-day, and 2 sachets in the evening). Each sachet was taken in half a glass of water.
The mandatory treatment period was from Day 1 to Day 4 or Day 5 (with a minimum of 24 sachets taken within 4 or 5 days). Treatment could continue from Day 5 up to Day 8 or 9 (with a maximum of 48 sachets taken within 8 or 9 days).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
9/430 • Number of events 9 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
2.1%
9/421 • Number of events 9 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
1.2%
5/430 • Number of events 5 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.71%
3/421 • Number of events 3 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.47%
2/430 • Number of events 2 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.71%
3/421 • Number of events 3 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.71%
3/421 • Number of events 4 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Proctalgia
|
0.47%
2/430 • Number of events 2 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
0.70%
3/430 • Number of events 3 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
1.7%
7/421 • Number of events 7 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
2/430 • Number of events 2 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.48%
2/421 • Number of events 2 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.48%
2/421 • Number of events 2 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Infections and infestations
Arthritis salmonella
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Infections and infestations
Urethritis
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
General disorders
Pyrexia
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/430 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.00%
0/421 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
|
Psychiatric disorders
Acrophobia
|
0.00%
0/430 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
0.24%
1/421 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 until 7 days after the end of the study treatment, up to 16 days.
The safety population included all randomised participants who received at least 1 dose of study treatment (except for those excluded from the analysis). Participants were analysed according to the actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor requires that reasonable opportunity be given to review the content and conclusions of any abstract, presentation, or paper before the material is submitted for publication or communicated. The sponsor will comment on the draft documents within the time period agreed in the contractual arrangements. Requested amendments will be incorporated by the author, provided they do not alter the scientific value of the material.
- Publication restrictions are in place
Restriction type: OTHER