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Tepilta® Versus Oxetacaine, Antacids and Placebo

NCT01336530 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-07

No results posted yet for this study

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.

Conditions

  • Radiation-induced Oesophagitis

Interventions

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.

Sponsors & Collaborators

  • Trium Analysis Online GmbH

    collaborator INDUSTRY

  • ICON plc

    collaborator INDUSTRY

  • Clinipace Worldwide

    collaborator INDUSTRY

  • MEDA Pharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Frank Bruns, Dr. med. · Hannover Medical School

  • Ursula Petzold, PhD · MEDA Pharma GmbH & Co. KG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Austria
  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336530 on ClinicalTrials.gov