Trial Outcomes & Findings for Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea (NCT NCT03045926)
NCT ID: NCT03045926
Last Updated: 2019-04-05
Results Overview
Baseline blood lead levels (BLL) were defined as the average between the available screening and pre-dose (Day-1) values. Values below the limit of detection (LOD) or below the lower limit of quantification (LLOQ) were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in BLL during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in BLL during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Screening and pre-dose Day -1 up to Day 125.
Results posted on
2019-04-05
Participant Flow
35 subjects with chronic functional diarrhoea were enrolled into this open label study in 2 study centres in the Netherlands and United Kingdom. The first subject started 24 August 2016 and last subject completed 9 May 2017.
73 subjects were screened for inclusion in the study, 38 subjects failed screening, and 35 met all the inclusion and none of the exclusion criteria. All 35 subjects received treatment with study medication.
Participant milestones
| Measure |
Smecta® Powder
Subjects received Smecta® (3 grams \[g\] of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Baseline characteristics by cohort
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The Intention-to-Treat (ITT) population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood lead levels (BLL) were defined as the average between the available screening and pre-dose (Day-1) values. Values below the limit of detection (LOD) or below the lower limit of quantification (LLOQ) were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in BLL during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in BLL during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
0.359 nanograms per millilitre (ng/mL)
Interval -0.576 to 1.294
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
3.907 nanograms per millilitre (ng/mL)
Interval 2.613 to 5.201
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
0.120 nanograms per millilitre (ng/mL)
Interval -0.823 to 1.063
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
0.306 nanograms per millilitre (ng/mL)
Interval -0.661 to 1.273
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
0.095 nanograms per millilitre (ng/mL)
Interval -0.886 to 1.076
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
0.308 nanograms per millilitre (ng/mL)
Interval -0.507 to 1.123
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
-0.096 nanograms per millilitre (ng/mL)
Interval -0.915 to 0.724
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
0.836 nanograms per millilitre (ng/mL)
Interval -0.163 to 1.835
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
2.539 nanograms per millilitre (ng/mL)
Interval 1.702 to 3.375
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
4.722 nanograms per millilitre (ng/mL)
Interval 3.581 to 5.863
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
6.094 nanograms per millilitre (ng/mL)
Interval 4.731 to 7.457
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
6.900 nanograms per millilitre (ng/mL)
Interval 5.338 to 8.462
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
6.866 nanograms per millilitre (ng/mL)
Interval 5.294 to 8.437
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
7.379 nanograms per millilitre (ng/mL)
Interval 5.823 to 8.935
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
6.865 nanograms per millilitre (ng/mL)
Interval 5.376 to 8.354
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
7.328 nanograms per millilitre (ng/mL)
Interval 5.783 to 8.874
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
8.248 nanograms per millilitre (ng/mL)
Interval 5.187 to 11.31
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
6.876 nanograms per millilitre (ng/mL)
Interval 5.208 to 8.545
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
7.632 nanograms per millilitre (ng/mL)
Interval 6.029 to 9.234
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
1.197 nanograms per millilitre (ng/mL)
Interval -0.543 to 2.936
|
|
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
-0.101 nanograms per millilitre (ng/mL)
Interval -1.633 to 1.431
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood aluminium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in blood aluminium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in blood aluminium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-13.708 ng/mL
Interval -30.05 to 2.633
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
-14.958 ng/mL
Interval -30.93 to 1.014
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
-6.225 ng/mL
Interval -28.37 to 15.92
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
-13.708 ng/mL
Interval -29.841 to 2.425
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
-1.688 ng/mL
Interval -32.375 to 29.0
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
-9.392 ng/mL
Interval -28.419 to 9.636
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
-14.181 ng/mL
Interval -31.092 to 2.73
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
-14.181 ng/mL
Interval -31.092 to 2.73
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
-11.733 ng/mL
Interval -30.416 to 6.951
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
-15.474 ng/mL
Interval -31.996 to 1.048
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
-2.884 ng/mL
Interval -33.668 to 27.9
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
-13.708 ng/mL
Interval -30.05 to 2.633
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
-13.708 ng/mL
Interval -28.874 to 1.457
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
-13.708 ng/mL
Interval -29.841 to 2.425
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
-14.958 ng/mL
Interval -30.93 to 1.014
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
-13.708 ng/mL
Interval -30.05 to 2.633
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
-7.142 ng/mL
Interval -30.474 to 16.191
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
-13.708 ng/mL
Interval -30.05 to 2.633
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
-14.958 ng/mL
Interval -30.93 to 1.014
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up
|
-13.708 ng/mL
Interval -30.05 to 2.633
|
|
Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
-13.708 ng/mL
Interval -30.05 to 2.633
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood arsenic concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in blood arsenic concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in blood arsenic concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
-0.067 ng/mL
Interval -0.302 to 0.168
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
0.034 ng/mL
Interval -0.298 to 0.366
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
0.640 ng/mL
Interval -0.189 to 1.469
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
0.420 ng/mL
Interval -0.209 to 1.05
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
0.359 ng/mL
Interval -0.239 to 0.956
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
0.350 ng/mL
Interval -0.223 to 0.922
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
0.507 ng/mL
Interval -0.322 to 1.336
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
-0.029 ng/mL
Interval -0.285 to 0.227
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
-0.003 ng/mL
Interval -0.305 to 0.3
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
-0.059 ng/mL
Interval -0.327 to 0.209
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
0.037 ng/mL
Interval -0.311 to 0.384
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
0.027 ng/mL
Interval -0.311 to 0.365
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
0.312 ng/mL
Interval -0.221 to 0.846
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
0.484 ng/mL
Interval -0.196 to 1.165
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
0.429 ng/mL
Interval 0.02 to 0.837
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
0.461 ng/mL
Interval -0.221 to 1.143
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
0.462 ng/mL
Interval -0.244 to 1.169
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
0.415 ng/mL
Interval -0.225 to 1.055
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
0.361 ng/mL
Interval -0.248 to 0.97
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
0.295 ng/mL
Interval -0.381 to 0.972
|
|
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
0.051 ng/mL
Interval -0.433 to 0.535
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood barium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in blood barium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in blood barium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
0.114 ng/mL
Interval -0.118 to 0.347
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
0.114 ng/mL
Interval -0.118 to 0.347
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
0.340 ng/mL
Interval -0.351 to 1.031
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
0.471 ng/mL
Interval 0.014 to 0.927
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
0.114 ng/mL
Interval -0.118 to 0.347
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
1.086 ng/mL
Interval -0.673 to 2.844
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
0.000 ng/mL
The confidence interval was not evaluable as blood barium concentrations were below LOD in the majority of subjects.
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
0.229 ng/mL
Interval -0.095 to 0.552
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
0.563 ng/mL
Interval -0.371 to 1.497
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
6.609 ng/mL
Interval -5.746 to 18.963
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
0.660 ng/mL
Interval -0.466 to 1.786
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
2.423 ng/mL
Interval -0.974 to 5.82
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
3.023 ng/mL
Interval -0.334 to 6.38
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
0.229 ng/mL
Interval -0.095 to 0.552
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
1.300 ng/mL
Interval -1.342 to 3.942
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
4.229 ng/mL
Interval -4.129 to 12.586
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
0.341 ng/mL
Interval -0.353 to 1.035
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
0.000 ng/mL
The confidence interval was not evaluable as blood barium concentrations were below LOD in the majority of subjects.
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
0.371 ng/mL
Interval -0.194 to 0.937
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
0.114 ng/mL
Interval -0.118 to 0.347
|
|
Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
0.000 ng/mL
The confidence interval was not evaluable as blood barium concentrations were below LOD in the majority of subjects.
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood cadmium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in blood cadmium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in blood cadmium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
0.017 ng/mL
Interval -0.018 to 0.053
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
-0.002 ng/mL
Interval -0.035 to 0.032
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
0.020 ng/mL
Interval -0.03 to 0.07
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
0.006 ng/mL
Interval -0.044 to 0.056
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
-0.003 ng/mL
Interval -0.052 to 0.047
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
0.015 ng/mL
Interval -0.041 to 0.071
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
-0.004 ng/mL
Interval -0.046 to 0.039
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
-0.006 ng/mL
Interval -0.064 to 0.053
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
0.033 ng/mL
Interval -0.028 to 0.095
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
-0.009 ng/mL
Interval -0.067 to 0.049
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
-0.009 ng/mL
Interval -0.066 to 0.049
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
-0.038 ng/mL
Interval -0.111 to 0.035
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
-0.025 ng/mL
Interval -0.094 to 0.044
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
-0.035 ng/mL
Interval -0.103 to 0.033
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
-0.029 ng/mL
Interval -0.079 to 0.022
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
0.025 ng/mL
Interval -0.031 to 0.081
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
-0.023 ng/mL
Interval -0.087 to 0.04
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
-0.020 ng/mL
Interval -0.082 to 0.043
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
0.034 ng/mL
Interval -0.042 to 0.11
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-0.073 ng/mL
Interval -0.164 to 0.018
|
|
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
-0.110 ng/mL
Interval -0.208 to -0.013
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood cobalt concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in blood cobalt concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in blood cobalt concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
-0.019 ng/mL
Interval -0.063 to 0.024
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
0.019 ng/mL
Interval -0.024 to 0.063
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
0.019 ng/mL
Interval -0.032 to 0.07
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
0.084 ng/mL
Interval 0.021 to 0.146
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
0.046 ng/mL
Interval -0.011 to 0.104
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
0.045 ng/mL
Interval -0.011 to 0.101
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
0.045 ng/mL
Interval -0.011 to 0.101
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
0.045 ng/mL
Interval -0.011 to 0.101
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
0.006 ng/mL
Interval -0.029 to 0.041
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
0.006 ng/mL
Interval -0.037 to 0.05
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
0.006 ng/mL
Interval -0.016 to 0.029
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
-0.007 ng/mL
Interval -0.052 to 0.039
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
0.019 ng/mL
Interval -0.015 to 0.054
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
0.032 ng/mL
Interval -0.018 to 0.082
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
0.045 ng/mL
Interval -0.011 to 0.101
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
0.032 ng/mL
Interval -0.018 to 0.082
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
0.019 ng/mL
Interval -0.024 to 0.063
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
0.032 ng/mL
Interval -0.018 to 0.082
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
0.019 ng/mL
Interval -0.024 to 0.063
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
0.084 ng/mL
Interval 0.021 to 0.146
|
|
Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-0.006 ng/mL
Interval -0.07 to 0.057
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood mercury concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in blood mercury concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in blood mercury concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
-0.005 ng/mL
Interval -0.046 to 0.036
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
0.012 ng/mL
Interval -0.035 to 0.058
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
-0.020 ng/mL
Interval -0.098 to 0.058
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
0.098 ng/mL
Interval 0.001 to 0.194
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
0.155 ng/mL
Interval -0.014 to 0.325
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
0.019 ng/mL
Interval -0.079 to 0.118
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
-0.017 ng/mL
Interval -0.064 to 0.031
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
-0.013 ng/mL
Interval -0.058 to 0.032
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
0.013 ng/mL
Interval -0.034 to 0.06
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
0.015 ng/mL
Interval -0.028 to 0.059
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
-0.041 ng/mL
Interval -0.156 to 0.075
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
-0.076 ng/mL
Interval -0.234 to 0.081
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
-0.008 ng/mL
Interval -0.143 to 0.128
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
-0.046 ng/mL
Interval -0.197 to 0.105
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
-0.085 ng/mL
Interval -0.224 to 0.055
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
-0.091 ng/mL
Interval -0.236 to 0.053
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
-0.113 ng/mL
Interval -0.262 to 0.036
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
-0.085 ng/mL
Interval -0.224 to 0.055
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
0.064 ng/mL
Interval -0.034 to 0.161
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
0.080 ng/mL
Interval -0.252 to 0.411
|
|
Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
0.112 ng/mL
Interval -0.167 to 0.39
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 125.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.
Baseline blood nickel concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in blood nickel concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in blood nickel concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 1
|
0.000 ng/mL
Interval -0.419 to 0.419
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 35
|
-0.257 ng/mL
Interval -0.812 to 0.298
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
0.643 ng/mL
Interval -0.475 to 1.761
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 1
|
0.000 ng/mL
Interval -0.562 to 0.562
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Second Dose Day 1
|
-0.257 ng/mL
Interval -0.569 to 0.055
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 1
|
0.132 ng/mL
Interval -0.563 to 0.828
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 1
|
0.129 ng/mL
Interval -0.288 to 0.545
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 1
|
0.129 ng/mL
Interval -0.546 to 0.803
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 2
|
0.714 ng/mL
Interval -0.387 to 1.816
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 8
|
-0.257 ng/mL
Interval -0.872 to 0.358
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 15
|
-0.257 ng/mL
Interval -0.872 to 0.358
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 22
|
0.265 ng/mL
Interval -0.307 to 0.837
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, First Dose Day 29
|
0.000 ng/mL
Interval -0.773 to 0.773
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
2 hours post-dose, First Dose Day 35
|
0.129 ng/mL
Interval -0.687 to 0.944
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Second Dose Day 35
|
-0.386 ng/mL
Interval -0.993 to 0.221
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Pre-dose, Third Dose Day 35
|
0.129 ng/mL
Interval -0.643 to 0.9
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
3 hours post-dose, Third Dose Day 35
|
0.000 ng/mL
Interval -0.676 to 0.676
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
6 hours post-dose, Third Dose Day 35
|
0.000 ng/mL
Interval -0.773 to 0.773
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 36 morning
|
-0.257 ng/mL
Interval -0.978 to 0.463
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
-0.514 ng/mL
Interval -1.472 to 0.443
|
|
Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period
Day 125 (End of Study)
|
1.414 ng/mL
Interval 0.198 to 2.63
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine lead levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine lead levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
0.040 ng/mL
Interval -0.168 to 0.248
|
|
Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
-0.027 ng/mL
Interval -0.232 to 0.177
|
|
Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-0.001 ng/mL
Interval -0.144 to 0.141
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine aluminium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine aluminium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
0.700 ng/mL
Interval -0.723 to 2.123
|
|
Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
-1.400 ng/mL
Interval -3.382 to 0.582
|
|
Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-3.500 ng/mL
Interval -7.119 to 0.119
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine arsenic levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine arsenic levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
-2.694 ng/mL
Interval -22.005 to 16.618
|
|
Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
-3.886 ng/mL
Interval -24.165 to 16.394
|
|
Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-2.467 ng/mL
Interval -22.357 to 17.423
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine barium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine barium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
1.493 ng/mL
Interval 0.917 to 2.07
|
|
Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
-0.188 ng/mL
Interval -0.643 to 0.266
|
|
Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-0.166 ng/mL
Interval -0.588 to 0.256
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine cadmium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine cadmium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
-0.051 ng/mL
Interval -0.114 to 0.011
|
|
Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
-0.026 ng/mL
Interval -0.09 to 0.039
|
|
Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
0.000 ng/mL
Interval -0.075 to 0.075
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine cobalt levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine cobalt levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
0.045 ng/mL
Interval -0.067 to 0.156
|
|
Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
0.019 ng/mL
Interval -0.073 to 0.111
|
|
Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
0.115 ng/mL
Interval -0.08 to 0.311
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine mercury levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine mercury levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
-0.049 ng/mL
Interval -0.117 to 0.02
|
|
Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
-0.024 ng/mL
Interval -0.074 to 0.025
|
|
Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
-0.049 ng/mL
Interval -0.117 to 0.02
|
SECONDARY outcome
Timeframe: Screening and pre-dose Day -1 up to Day 95.Population: The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.
Baseline urine nickel levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in urine nickel levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.
Outcome measures
| Measure |
Smecta® Powder
n=35 Participants
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period
Day 35
|
-0.090 ng/mL
Interval -0.423 to 0.243
|
|
Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period
Day 65 (follow-up)
|
0.080 ng/mL
Interval -0.195 to 0.356
|
|
Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period
Day 95 (follow-up)
|
0.401 ng/mL
Interval 0.034 to 0.768
|
Adverse Events
Smecta® Powder
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Smecta® Powder
n=35 participants at risk
Subjects received Smecta® (3 g of diosmectite), ingested three times a day, in the morning, at noon and in the evening, every day from Day 1 to Day 35 before meals in the fasting state.
Subjects were followed up for up to 3 months after the last dose of Smecta® administered on Day 35, up to Day 125.
|
|---|---|
|
Nervous system disorders
Headache
|
37.1%
13/35 • Number of events 21 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
25.7%
9/35 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Cystitis
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Otitis media
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Tooth abscess
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
5/35 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
4/35 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.6%
3/35 • Number of events 6 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.7%
2/35 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Anal fissure
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
General disorders
Influenza like illness
|
8.6%
3/35 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
5/35 • Number of events 5 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • Number of events 8 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.9%
1/35 • Number of events 7 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Onycholasis
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Investigations
Blood glucose increased
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Investigations
Transferrin increased
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Investigations
Blood iron increased
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
2/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Chemical injury
|
2.9%
1/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
1/35 • Number of events 3 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.9%
1/35 • Number of events 2 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
2.9%
1/35 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).
TEAEs are reported for the Safety population which consisted of all subjects who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor shall have the right and title to all documentation, reports, records, data, specimens or other work product generated in connection with the performance of the study. All materials, documents, and information of every kind and description supplied by the sponsor (with the exception of that which is in the public domain), and any sponsor intellectual property shall be the sole and exclusive property of the the sponsor.
- Publication restrictions are in place
Restriction type: OTHER