Clinical Trial Results:
An Open-Label, Uncontrolled, Multicenter Study to Evaluate the Safety, Local Tolerability, Systemic Exposure, and Efficacy of 1% GPB Cream in Adolescents With Severe Primary Axillary Hyperhidrosis
PIP decision number updates: P/0565/2021; P/0497/2023
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Summary
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EudraCT number |
2022-000922-46 |
Trial protocol |
DE PL |
Global end of trial date |
06 Mar 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Sep 2024
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First version publication date |
22 Sep 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GPBK-08/2018
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05863104 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Dr. August Wolff GmbH & Co.KG Arzneimittel
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Sponsor organisation address |
Sudbrackstraße 56, Bielefeld, Germany, 33611
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Public contact |
Department of Clinical Affairs , Dr. August Wolff GmbH & Co. KG Arzneimittel, ClinicalTrialDisclosures@drwolffgroup.com
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Scientific contact |
Department of Clinical Affairs , Dr. August Wolff GmbH & Co. KG Arzneimittel, ClinicalTrialDisclosures@drwolffgroup.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002383-PIP01-18 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
25 Apr 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
06 Mar 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Mar 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The evaluation of the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.
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Protection of trial subjects |
This study was in compliance with the ethical principles of current applicable regulations, International Council for Harmonisation (ICH) of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements. All regulatory requirements relevant to the safety of the study participants were followed during the conduct of the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 May 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 33
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Country: Number of subjects enrolled |
Germany: 11
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Worldwide total number of subjects |
44
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EEA total number of subjects |
44
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
44
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Adolescents of both sexes between 12 and 17 years with a body mass index percentile ≥10 and ≤90 and with a patient-rated hyperhidrosis severity score of ≥5 at Screening 2 and Day 1 that were diagnosed with severe primary axillary hyperhidrosis. | ||||||||||||
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Pre-assignment
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Screening details |
62 adolescents were screened. 44 patients were eligible to participate and enrolled in this study. 42 patients were treated as 2 patients withdrew consent before start of treatment. | ||||||||||||
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Period 1
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Period 1 title |
1% Glycopyrronium bromide (GPB) cream (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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1% glycopyrronium bromide (GPB) cream | ||||||||||||
Arm description |
In this arm, 42 patients were treated with 1 % GPB cream for 8 weeks, 40 patients completed the treatment until week 8, followed by a safety follow-up phase of 14 days. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
1% GPB cream
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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Dosage and administration details |
Topical administration to both axillae, once daily for 4 weeks starting on Day 1, up to Day 29. After week 4 topical administration as needed up to Day 57 (at least twice per week and at most once daily).
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: In this study, 44 patients were enrolled. 2 patients withdrew consent before start of treatment, i.e. the first application of the IMP. Therefore, the number of subjects reported to be in the baseline period is 42. |
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Baseline characteristics reporting groups
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Reporting group title |
1% Glycopyrronium bromide (GPB) cream
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Reporting group description |
44 patients were enrolled and as 2 patients withdrew consent before start of therapy, 42 patients were treated with 1% GPB cream for 4 weeks daily and then for 4 weeks flexible (ie, at least twice a week up to once daily, as needed) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
1% GPB FAS
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The FAS includes all patients enrolled who applied the 1% GPB cream at least once, i.e. all patients from SAF. The FAS is used key secondary and secondary endpoint analysis.
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Subject analysis set title |
1% GPB mSAF
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The mSAF (modified SAF) includes all patients of the SAF, who were assessed for systemic exposure and had at least an assessment at Day 1 and an additional assessment after Day 1. The mSAF is used for the analysis of systemic exposure.
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Subject analysis set title |
1% GPB PPS
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The PPs includes all patients of the FAS without any major PDs.
PDs were reviewed during a data review meeting held before the data base lock to identify major deviations leading to the exclusion of patients from the PPS. The PPS is used for supplementary analyses of key secondary and selected secondary endpoints.
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Subject analysis set title |
1% GPB SAF
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The SAF includes all patients enrolled who applied the IMP at least once. It is used for safety analyses including primary safety analyses.
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End points reporting groups
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Reporting group title |
1% glycopyrronium bromide (GPB) cream
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Reporting group description |
In this arm, 42 patients were treated with 1 % GPB cream for 8 weeks, 40 patients completed the treatment until week 8, followed by a safety follow-up phase of 14 days. | ||
Subject analysis set title |
1% GPB FAS
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The FAS includes all patients enrolled who applied the 1% GPB cream at least once, i.e. all patients from SAF. The FAS is used key secondary and secondary endpoint analysis.
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Subject analysis set title |
1% GPB mSAF
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The mSAF (modified SAF) includes all patients of the SAF, who were assessed for systemic exposure and had at least an assessment at Day 1 and an additional assessment after Day 1. The mSAF is used for the analysis of systemic exposure.
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Subject analysis set title |
1% GPB PPS
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The PPs includes all patients of the FAS without any major PDs.
PDs were reviewed during a data review meeting held before the data base lock to identify major deviations leading to the exclusion of patients from the PPS. The PPS is used for supplementary analyses of key secondary and selected secondary endpoints.
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Subject analysis set title |
1% GPB SAF
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The SAF includes all patients enrolled who applied the IMP at least once. It is used for safety analyses including primary safety analyses.
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End point title |
Primary systemic exposure endpoint: Absolute change in glycopyrronium plasma concentration from Baseline to Day 15 [1] | ||||||||||||
End point description |
Absolut change of GP Plasma concentration from Baseline to Day 15 will be assessed on the mSAF using the median absolute change from Baseline. If the value on Day 15 is missing, the value of Day 8 wil be carried forward and used instead using LOCF. In the analysis without outliers, outliers at Baseline (>0 pg/mg) were excluded from the analysis, as applicable.
Hahn-Meeker Confidence Interval (95%) for the median change from Baseline:
Including outliers (N=22): 4.490; 23.400
Without outliers (N=19): 4.490; 23.400
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End point type |
Primary
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End point timeframe |
Baseline to Day 15
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to technical limitations is was not possible to add the 1-sided t-test for this endpoint. For this reason, the statistics are described in the end point description. |
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| Notes [2] - Without outliers: 19 |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Primary safety endpoint: Number of patients with ADRs during treatment [3] | ||||||||||
End point description |
In the primary endpoint analysis, ie, the number of patients with ADRs during treatment, 2 patients (out of 41 patients; 4.9%) had an ADR during treatment. Accordingly, 95.1% (39 of 41 patients) did not have an ADR during the study. 1 patient who prematurely discontinued the study and had no ADR was excluded from the analysis. Adverse drug reactions are defined as TEAEs certainly, probably, possibly related to the IMP, or with missing relationship assessment
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End point type |
Primary
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End point timeframe |
Baseline to Day 57
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed in this endpoint. The percentages of patients with and without ADRs are indicated in the description. |
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| Notes [4] - Patients who were discontinued prematurely are included in the analysis. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Primary tolerability endpoint: Number of patients with a local tolerability assessment based on the skin reaction score with a score >0 [5] | ||||||
End point description |
Number of patients with a local tolerability assessment based on the skin reaction score with a score >0. None of the 40 patients assessed had a score >0 during treatment. 2 patients who discontinued prematurely and had no score >0 were excluded from the analysis.
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End point type |
Primary
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End point timeframe |
Baseline to Day 57
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to technical limitations is was not possible to add the 1-sided t-test for this endpoint. For this reason, the statistics are described in the end point description. |
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| Notes [6] - 2 patients who discontinued prematurely and had no score >0 were excluded from the analysis. |
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| No statistical analyses for this end point | |||||||
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End point title |
Secondary systemic exposure endpoint: Absolute change in glycopyrronium plasma concentration from Baseline to Day 8 | ||||||||||||
End point description |
Absolute change in glycopyrronium plasma concentration from Baseline to Day 8 is described including outliers and without outliers and was analyzed with median and a 95% Hahn-Meeker confidence interval for the median change from Baseline. Missing values at Day 15 were replaced with valid Day 8 values using LOCF.
In the analysis without outliers, outliers at Baseline (>0 pg/mg) were excluded from the analysis as applicable.
95% Hahn Meeker Confidence Intervall for the median change from Baseline (mSAF):
Including outliers (N=22): 3.690; 24.200
Without outliers (N=20): 3.690; 22.800
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End point type |
Secondary
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End point timeframe |
Baseline to Day 8
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| Notes [7] - Including outliers: 22 Without outliers: 20 |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Key secondary efficacy endpoint: Absolute change in logarithmic values of total sweat production from Baseline to Day 29 | ||||||||||||
End point description |
Absolut change in logarithmic values of total sweat production assessed by gravimetric measurement from Baseline to Day 29 (FAS, PPS).
1-sample t-test for the change from Baseline (2-sided, α = 0.05):
FAS: p-value = 0.0004
PPS: p-value = 0.0165
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End point type |
Secondary
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End point timeframe |
Baseline to Day 29
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Secondary systemic exposure endpoint: Absolute change in glycopyrronium plasma concentration from Day 8 to Day 15 | ||||||||||||
End point description |
Absolute change in glycopyrronium plasma concentration from Day 8 to Day 15 is described including outliers and without outliers and was analyzed with median and a 95% Hahn-Meeker confidence interval for the median change from Baseline. Missing values at Day 15 were replaced with valid Day 8 values using LOCF.
In the analysis without outliers, outliers at Baseline (>0 pg/mg) were excluded from the analysis as applicable.
95% Hahn Meeker Confidence Intervall for the median change from Baseline (mSAF):
Including outliers (N=19): -3.800; 3.910
Without outliers (N=18): -5.300; 2.540
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End point type |
Secondary
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End point timeframe |
Day 8 to Day 15
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| Notes [8] - Including outliers: 19 Without outliers: 18 |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Secondary efficacy endpoint: Absolute change in logarithmic values of total sweat production from Baseline to Day 57 | ||||||||||||
End point description |
Absolute change in logarithmic values of total sweat production assessed by gravimetric measurement from Baseline to Day 57 (FAS, PPS).
1-sample t-test (2-sided, α=0.05):
FAS: p-value <0.0001
PPS: p-value = 0.0003
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End point type |
Secondary
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End point timeframe |
Baseline to Day 57
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Secondary efficacy endpoint: Absolute change in logarithmic values of total sweat production from Day 29 to Day 57 | ||||||||
End point description |
Absolute change in logarithmic values of total sweat production from Day 29 to Day 57 (FAS).
1-sample t-test (2-sided, α = 0.05):
FAS: p-value = 0.2858
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End point type |
Secondary
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End point timeframe |
Day 29 to Day 57
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| No statistical analyses for this end point | |||||||||
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End point title |
Secondary efficacy endpoint: Relative change in total sweat production from Baseline to Day 29 and Day 57 | ||||||||||||||||||
End point description |
Relative change in total sweat production from Baseline to Day 29 and Day 57 (FAS, PPS).
Wilcoxon signed rank test for change from BL with 95% Hahn-Meeker CI (2-sided, α = 0.05):
FAS: Day 29 p-value <0.0001; (-88.600;-57.670)
Day 57 p-value <0.0001; (-94.950;-75.960)
PPS: Day 29 p-value = 0.0025; (-84.360;-56.150)
Day 57 p-value<0.0001; (-94.950;-68.130)
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End point type |
Secondary
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End point timeframe |
Baseline to Day 29 and Day 57
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| Notes [9] - Day 29: N=34 Day 57: N=37 [10] - Day 29: N=25 Day 57: N=27 |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Secondary efficacy endpoint: Relative change in total sweat production from Day 29 to Day 57 | ||||||||
End point description |
Relative change in total sweat production from Day 29 to Day 57 (FAS).
Wilcoxon signed rank test (2-sided, α = 0.05):
FAS (n=32): p-value=0.7450
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End point type |
Secondary
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End point timeframe |
Day 29 to Day 57
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| Notes [11] - Numer ober patients in analysis |
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| No statistical analyses for this end point | |||||||||
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End point title |
Secondary efficacy endpoint: Proportion of responders assessed by gravimetric measurement at Day 29 | ||||||||||||||
End point description |
Proportion of responders assessed by gravimetric measurement at Day 29. Patients with missing values were considered non responders. Patients will be defined as responder if a certain criterium (e.g., sweat reduction of ≥50%) is reached. All other patients will be defined as non-responder.
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End point type |
Secondary
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End point timeframe |
Day 29
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Secondary efficacy endpoint: Proportion of responders assessed by gravimetric measurement at Day 57 | ||||||||||||||
End point description |
Proportion of responders assessed by gravimetric measurement at Day 57. Patients with missing values were considered non responders. Patients will be defined as responder if a certain criterium (e.g., sweat reduction of ≥50%) is reached. All other patients will be defined as non-responder.
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End point type |
Secondary
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End point timeframe |
Day 57
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Secondary efficacy endpoint: Absolute change in patient-rated hyperhidrosis severity from Baseline to Day 29 and Day 57 | ||||||||||||||||||
End point description |
Absolute changes in PRHS (patient-rated hyperhidrosis severity; 11-point scale from 0 to 10) from Baselinte to Day 29 and Day 57 (FAS, PPS).
1-sample t-test for the change from Baseline (2-sided, α = 0.05):
FAS: Day 29 p-value<0.0001, Day 57 p-value<0.0001
PPS: Day 29 p-value<0.0001, Day 57 p-value<0.0001
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End point type |
Secondary
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End point timeframe |
Baseline to Day 29 and Day 57
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Secondary efficacy endpoint: Absolute change in patient-rated hyperhidrosis severity from Day 29 to Day 57 | ||||||||
End point description |
Absolute changes in PRHS (patient-rated hyperhidrosis severity; 11-point scale from 0 to 10) from Day 29 to Day 57(FAS).
1-sample t-test for the change to Day 57 (2-sided, α = 0.05):
FAS: p-value = 0.0012
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End point type |
Secondary
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End point timeframe |
Day 29 to Day 57
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| No statistical analyses for this end point | |||||||||
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End point title |
Secondary efficacy endpoint: Absolute change in the children’s dermatology life quality index score from Baseline to Day 29 and Day 57 | ||||||||||||||||||
End point description |
Absolute change in the children’s dermatology life quality index score (CDLQI) from Baseline to Day 29 and Day 57. If 1 answer was missing, the missing answer was scored with 0. If more than 1 answer was missing, no CDLQI score was calculated. Missing baseline values were replaced with the last non-missing values before Day 1.
1-sample t-test for the change from Baseline (2-sided, α = 0.05):
FAS: Day 29 p-value<0.0001, Day 57 p-value<0.0001
PPS: Day 29 p-value=0.0005, Day 57 p-value<0.0001
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End point type |
Secondary
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End point timeframe |
Baseline to Day 29 and Day 57
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Secondary efficacy endpoint: Absolute change in the children’s dermatology life quality index score from Day 29 to Day 57 | ||||||||
End point description |
Absolute change in the children’s dermatology life quality index score (CDLQI) from Day 29 to Day 57.
1-sample t-test for the change to Day 57 (2-sided, α = 0.05):
FAS: p-value=0.1493
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End point type |
Secondary
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End point timeframe |
Day 29 to Day 57
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline to Day 57
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Adverse event reporting additional description |
In this part, non-serious adverse events are described as Treatment-emergent adverse events (TEAEs), i.e. all AEs with start date on or after the date of IMP start.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.1
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Reporting groups
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Reporting group title |
1% GPB SAF - Baseline to Day 29
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Reporting group description |
Treatment-emergent adverse events which started up to and including Day 29; patients self-administered the 1% GPB cream once daily in this period (SAF, N=42) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
1% GPB SAF - After Day 29 to Day 57
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Reporting group description |
Treatment-emergent adverse events which started after Day 29 up to and including Day 57; patients self-administered the 1% GPB cream flexible in this period (at least twice per week and at most once daily; SAF, N=42) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
1% GPB SAF - Baseline to Day 57
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Reporting group description |
Treatment-emergent adverse events which started up to and including Day 57 (SAF, N=42) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 Jul 2023 |
Amendment 1.0 to protocol Version 4.0, dated 07-Jul-2023:
Reworded safety endpoint for clarity and updatet list of abbreviations;
Changed inclusion criterion 1 for clarity; Added specifitcation of timepoint of eligibility confirmation to inclusion criterion 2; Addition of medications causing secondary hyperhydrosis to exclusion critoerion 1; Corrrection of inclusion criterion 4; Editorial correction to exclusion criterion 19; Addition of sympathomimetics to list of prohibited concomitant medications; Addition additional drug screening parameters (will not be recorded by study data).
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
