Sponsor study identifier
interventional
80
1 country
4
Study Start
September 14, 2023
Actual (reported)Primary Completion
November 9, 2023
Actual (reported)Study Completion
December 13, 2023
Actual (reported)This study is a multi center, multiple dose, open label trial to evaluate the adhesion of TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare adhesion assessment methods.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 13, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 10, 2023
Actual (reported)September 14, 2023
Actual (reported)September 18, 2023
Actual (reported)November 9, 2023
Actual (reported)December 13, 2023
Actual (reported)Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
Assessment/estimation by site staff with marked TK-254RX by site staff: A listing of individual values of percentage will be presented per time point and subject. Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by site staff (percentage values).
5 minutes prior to removal,
Characterization of adhesion by visual estimation of subjects
before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects
before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
Comparison of the adhesion assessments between subjects and study staff
5minutes prior to removal
Characterization of local tolerability during treatment
within 5 minutes after removal of each patch
For Group1, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Lower Arm, Day2: Lower thigh, Day3: Ankle
For Group2, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Upper Arm, Day2: Upper thigh, Day3: Lower leg
Two TK-254RX per day to predetermined application site
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Esflurbiprofen hydrogel patch 165 mg (EFHP)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TRANSDERMAL PATCH
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Esflurbiprofen hydrogel patch 165 mg (EFHP)
Named ingredient: Esflurbiprofen
View registry recordMedical Practice Ebert
Brühl, Germany
Medical practice Pabst
Fürstenfeldbruck, Germany
Medical practice Gastl
Gilching, Germany
Medical Pracitice Schaale/Bücheler
Rheinbach, Germany
Kenichi Nishiyama
Teikoku Seiyaku Co., Ltd.
80 participants (actual enrollment reported by the registry).
First Submitted
September 10, 2023
First Posted
September 18, 2023
Study Start
September 14, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 9, 2023
Actual (reported)Study Completion
December 13, 2023
Actual (reported)Last Updated
April 12, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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