NCT01336530

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

Terminated Phase 3 Last updated 4 February 2022

What this trial tests

Phase 3 trial testing oxetacaine, aluminium and magnesium hydroxide in Radiation-induced Oesophagitis in 40 participants. Terminated before completion.

Timeline

1 April 2011

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	MEDA Pharma GmbH & Co. KG
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	1 April 2011
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	32 locations across Austria, Germany

Drugs / interventions tested

• oxetacaine, aluminium and magnesium hydroxide — full drug profile →
• oxetacaine — full drug profile →
• magnesium and aluminium hydroxide — full drug profile →
• Vehicle

Conditions studied

• Radiation-induced Oesophagitis — all drugs for Radiation-induced Oesophagitis →

Sponsor

MEDA Pharma GmbH & Co. KG — full company profile →

Who can join

18 and older, any sex, with Radiation-induced Oesophagitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
  Time frame: up to 11 weeks

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adaptive designs undertaken in clinical research: a review of registered clinical trials.
   Hatfield I, Allison A, Flight L, Julious SA, et al · · 2016 · cited 62× · PMID 26993469 · DOI 10.1186/s13063-016-1273-9
2. Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
   Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4