NCT01336530

Tepilta® Versus Oxetacaine, Antacids and Placebo

Clinical Trial to Assess the Efficacy of Fixed Combination Product Tepilta® in the Treatment of Radiation-induced Oesophagitis Compared to Its Active Ingredients Oxetacaine and Antacids, and to Placebo

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Tepilta® Suspension is indicated for treatment of pain in the upper digestive system induced by radiation therapy, in particular for radiation-induced oesophagitis.

Conditions

• Radiation-induced Oesophagitis

Interventions

Type	Name	Description
DRUG	oxetacaine, aluminium and magnesium hydroxide	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.
DRUG	oxetacaine	20mg/10ml oxetacaine. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
DRUG	magnesium and aluminium hydroxide	196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
OTHER	Vehicle	Placebo suspension for oral intake 3-6 times per day for a maximum of 11 weeks.

Timeline

• Start date: 2011-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2011-04-18
• Last updated: 2022-02-07

Locations

32 sites across 2 countries: Austria, Germany