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

MEDA Pharma GmbH & Co. KG32 sites in 2 countries40 target enrollmentApril 2011

ConditionsRadiation-induced Oesophagitis

InterventionsVehicle oxetacaine, aluminium and magnesium hydroxide oxetacaine magnesium and aluminium hydroxide

Drugsoxetacaine, aluminium and magnesium hydroxide oxetacaine magnesium and aluminium hydroxide

Overview

Phase: Phase 3
Intervention: Vehicle
Conditions: Radiation-induced Oesophagitis
Sponsor: MEDA Pharma GmbH & Co. KG
Enrollment: 40
Locations: 32
Primary Endpoint: Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

January 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MEDA Pharma GmbH & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female ≥ 18 years.
•Score = 0 on NRS for oesophageal pain.
•Radiotherapy (RT) or combined radio-chemotherapy (RCT) of a solid tumour in head/neck/thorax region. A minimum length of 5 cm of the oesophagus must be included in high-dose radiation field.
•Duration of RT 5 to 8 weeks.
•Single radiation dosage of fractionated RT 1.8 to 2.0 Gy/day, of intensity-modulated RT (IMRT) 1.5 to 2.3 Gy/day, each for 5 days a week (single frequency deviations are allowed presuming that intended duration of RT remains 5 to 8 weeks).
•First radiation in the intended radiation area.
•Written informed consent.
•Randomisation criteria:
•Appearance of oesophageal pain as follows: Score ≥ 2 on Numeric Rating Scale (NRS) for pain during main daily meals is reached at least once.
•At least 20 Gy of the dose of radiation therapy in oesophageal area remaining.

Exclusion Criteria

•History of allergic reaction to the study medication or its excipients (i.e. aluminium or magnesium hydroxide, oxetacaine, any other ingredient of study medication).
•Pregnancy, breast-feeding or planned pregnancy during the study.
•Known hypermagnesaemia.
•Known hypophosphataemia.
•Clinically significant obstipation, as judged by the investigator.
•Acute appendicitis.
•Total intended radiation dose at lips and the anterior oral cavity \> 60% of total intended radiation dose at the swallowing process (pharynx, oesophagus).
•Hyper-fractionated RT.
•Intended naso-gastral tubes.
•Primary tumour of the cranial base, brain, oral cavity, lips, naso-pharynx, para-nasal sinuses.

Arms & Interventions

Placebo

Intervention: Vehicle

Tepilta®

Intervention: oxetacaine, aluminium and magnesium hydroxide

Oxetacaine

Intervention: oxetacaine

Antacids

Intervention: magnesium and aluminium hydroxide

Outcomes

Primary Outcomes

Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).

Time Frame: up to 11 weeks

Secondary Outcomes

Pain intensity recorded on NRS with scores 0-10(up to 11 weeks)
ASPO: WHO analgesic pain ladder(up to 11 weeks)
Incidence of artificial nutrition due to radiation-induced oesophagitis(up to 11 weeks)
Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis(up to 11 weeks)
Loss of body weight(up to 11 weeks)
Swallowing disorder recorded on NRS with scores 0-10(up to 11 weeks)
Duration of pain medication intake after the end of Radiation Therapy(up to 11 weeks)
Adapted CTCAE grade(up to 11 weeks)