This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre trial with 4 parallel treatment groups. The design is adaptive group-sequential with two interim analyses, possible sample size re-estimation after the first or second interim analysis and drop-the-loser approach. The study design was primarily chosen to show superior efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety is a secondary objective.
Tepilta® Suspension is indicated for treatment of pain in the upper digestive system induced by radiation therapy, in particular for radiation-induced oesophagitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
20mg/10ml oxetacaine, 196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
20mg/10ml oxetacaine. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
Time frame: up to 11 weeks
ASPO: WHO analgesic pain ladder
ASPO = Additional systemic pain medication for oesophagitis
Time frame: up to 11 weeks
Pain intensity recorded on NRS with scores 0-10
NRS = Numeric Rating Scale
Time frame: up to 11 weeks
Swallowing disorder recorded on NRS with scores 0-10
NRS = Numeric Rating Scale
Time frame: up to 11 weeks
Adapted CTCAE grade
CTCAE = Common Terminology Criteria for Adverse Events Severity of oesophageal symptoms will be evaluated by the investigator according to an adapted CTCAE grading system. In contrast to the original CTCAE classification the adapted version foreseen to be used in this study distinguishes level 2a and 2b. 2a = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly pureed or soft diet, 2b = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly liquid diet.
Time frame: up to 11 weeks
Incidence of artificial nutrition due to radiation-induced oesophagitis
Time frame: up to 11 weeks
Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis
Time frame: up to 11 weeks
Duration of pain medication intake after the end of Radiation Therapy
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Placebo suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Universitätsklinik für Strahlentherapie-Radioonkologie
Innsbruck, Austria
Universitätsklinikum Aachen
Aachen, Germany
RADIO LOG Strahlentherapie Altötting
Altötting, Germany
please contact Dr. Ingrid Schwienhorst/MEDA for details
Bad Homburg, Germany
VIVANTES Klinikum Neukölln
Berlin, Germany
Strahlenheilkunde Westend
Berlin, Germany
Franziskus Hospital
Bielefeld, Germany
Klinik für Hämatologie, Onkologie & Palliativmedizin
Bochum, Germany
Strahlentherapie Bonn-Rhein-Sieg
Bonn, Germany
...and 22 more locations
Time frame: up to 11 weeks
Loss of body weight
Time frame: up to 11 weeks