Clinical Trial Results:
Single-group, open study on the systemic bioavailability, safety and local tolerability of a new gel formulation of Somatoline¿ in 30 healthy women.
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Summary
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EudraCT number |
2018-002380-26 |
Trial protocol |
IT |
Global end of trial date |
14 May 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
13 May 2021
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First version publication date |
13 May 2021
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Other versions |
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Summary report(s) |
CSR |
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 |
Somagel
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Società Italo Britannica L. Manetti – H. Roberts & C. per Azioni
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Sponsor organisation address |
Via Baldanzese, 177, , Calenzano/Florence, Italy, 50041
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Public contact |
Cristina Sabatini, Società Italo Britannica L. Manetti – H. Roberts & C. per Azioni, 39 0558835320, csabatini@manettiroberts.it
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Scientific contact |
Cristina sabatini , Società Italo Britannica L. Manetti – H. Roberts & C. per Azioni, 39 055 88 35 320, csabatini@manettiroberts.it
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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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 |
01 Oct 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 May 2019
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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 primary objective of the study is to assess the systemic bioavailability of l-T4 in female subjects with after repeated cutaneous of a gel formulation of Somatoline¿ for 28 days.
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Protection of trial subjects |
NA
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Background therapy |
NA | ||
Evidence for comparator |
NA | ||
Actual start date of recruitment |
28 Jan 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Italy: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
0
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Adults (18-64 years) |
30
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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 |
Women from 18 to 50 years of age that demonstrate the willingness to be part of the study that accept study procedures signing the IC. | ||||||
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Pre-assignment
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Screening details |
Healthy women were enrolled in the study if they met all the inclusion criteria and none of the exclusion criteria. | ||||||
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Period 1
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Period 1 title |
Overall trial (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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Only one arm was present. | ||||||
Arm description |
The study was open with a single-group and, therefore, no randomization procedure was in place. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Somatoline gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Percutaneous use
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Dosage and administration details |
The women enrolled into the study were instructed to apply Somatoline® 10 grams gel – corresponding to l-T4 10 mg and escin 30 mg - on each thigh per day during the first 2 days (20 grams per day in total, corresponding to l-T4 20 mg and escin 60 mg), followed by 5 grams per thigh (10 grams per day in total, corresponding to l-T4 10 mg and escin 30 mg) until the end of a 4-week period starting from the day the first dose was applied.
The women were instructed and required to apply the product on the skin and then to massage the skin of the entire thigh for several minutes until complete percutaneous absorption.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
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Subject analysis sets
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Subject analysis set title |
Statistical Plan
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The final analysis was performed after database lock on data transferred from SAS-PheedIt (eCRF) and after the finalization and approval of the SAP document. Three populations were defined for use in the descriptive and inferential statistical analyses: the Safety Population, the ITT Population, and the PP Population.
• “INTENTION TO TREAT” (ITT population): all subjects who received the study drug and who participated in at least one post-baseline assessment;
• “PER PROTOCOL” (PP Population): all subjects who concluded the study without important protocol deviations or violations;
• “SAFETY” (Safety Population): all subjects who will be received at least one dose of the study drug.
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End points reporting groups
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Reporting group title |
Only one arm was present.
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Reporting group description |
The study was open with a single-group and, therefore, no randomization procedure was in place. | ||
Subject analysis set title |
Statistical Plan
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The final analysis was performed after database lock on data transferred from SAS-PheedIt (eCRF) and after the finalization and approval of the SAP document. Three populations were defined for use in the descriptive and inferential statistical analyses: the Safety Population, the ITT Population, and the PP Population.
• “INTENTION TO TREAT” (ITT population): all subjects who received the study drug and who participated in at least one post-baseline assessment;
• “PER PROTOCOL” (PP Population): all subjects who concluded the study without important protocol deviations or violations;
• “SAFETY” (Safety Population): all subjects who will be received at least one dose of the study drug.
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End point title |
The primary endpoint | |||||||||
End point description |
The primary endpoint was to compare the pre-treatment plasma concentrations of l-T4 with those observed 24 hours, 14 days and 28 days after a cutaneous repeated application of Somatoline® gel, and 14 days after the last application of the gel (Day 42 of follow-up).
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End point type |
Primary
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End point timeframe |
The primary endpoint was to compare the pre-treatment plasma concentrations of l-T4 with those observed 24 hours, 14 days and 28 days after a cutaneous repeated application of Somatoline® gel, and 14 days after the last application of the gel (Day 42 of f
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Statistical analysis title |
Statistical analysis | |||||||||
Statistical analysis description |
The study has been aimed at investigating the bioavailability of l-T4 (primary objective) after a repeated cutaneous application of Somatoline® gel. Moreover the plasma levels of T3, rT3 and TSH were also evaluated with the objective to rule out a putative transcutaneous absorption of l-T4, as active ingredient of Somatoline® gel, and its interference on systemic thyroid homeostasis. Finally, the local and systemic tolerability of Somatoline® gel were explored.
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Comparison groups |
Only one arm was present. v Statistical Plan
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
≥ 0.05 | |||||||||
Method |
ANOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
11
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Confidence interval |
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99% | |||||||||
sides |
2-sided
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lower limit |
9.8 | |||||||||
upper limit |
12.2 | |||||||||
Variability estimate |
Standard deviation
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Dispersion value |
1.2
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End point title |
The seconday end point | |||||||||
End point description |
The secondary endpoint was to compare the plasma concentrations of T3, rT3, and TSH with those observed 24 hours, 14 days and 28 days after a cutaneous repeated application of Somatoline® gel, and 14 days after the last application of the gel (Day 42 of follow-up).
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End point type |
Secondary
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End point timeframe |
The secondary endpoint was to compare the plasma concentrations of T3, rT3, and TSH with those observed 24 hours, 14 days and 28 days after a cutaneous repeated application of Somatoline® gel, and 14 days after the last application of the gel (Day 42 of f
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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 |
Overall the trial
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Adverse event reporting additional description |
Overall eight (8) subjects reported at least one AE during the study. Eighteen (18) AE were reported durign treatment period and one (1) during follow up. No SAE or death were reported.
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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 |
22
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Reporting groups
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Reporting group title |
All the subjects of the study
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Reporting group description |
All the women enrolled in the study were part of the same group. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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 | |||
