Tepilta® Versus Oxetacaine, Antacids and Placebo

Exclusion Criteria

• •1. History of allergic reaction to the study medication or its excipients (i.e. aluminium or magnesium hydroxide, oxetacaine, any other ingredient of study medication).
• •2. Pregnancy, breast-feeding or planned pregnancy during the study.
• •3. Known hypermagnesaemia.
• •4. Known hypophosphataemia.
• •5. Clinically significant obstipation, as judged by the investigator.
• •6. Acute appendicitis.
• •7. Total intended radiation dose at lips and the anterior oral cavity \> 60% of total intended radiation dose at the swallowing process (pharynx, oesophagus).
• •8. Hyper-fractionated RT.
• •9. Intended naso-gastral tubes.
• •10. Primary tumour of the cranial base, brain, oral cavity, lips, naso-pharynx, para-nasal sinuses.
• •11. Known bone metastases.
• •12. Reflux oesophagitis 3 months prior to the study.
• •13. Continuous systemic pain treatment at the beginning of RT. Systemic pain medication for oesophagitis prior to randomisation must not be taken.
• •14. Concomitant treatment with tetracyclines, cinolone derivatives (ciprofloxacin, ofloxacin, enoxacin, norfloxacin), cheno-desoxycholic acid, sodium fluoride, local anaesthetics (other than those used as study medication).
• •15. Patients relying on levothyroxine after resection of thyroid carcinoma being hypothyroid and patients relying on levothyroxine due to other reasons not being euthyroid.
• •16. Artificial nutrition at the beginning of radiation.
• •17. Drug (licit and illicit) or alcohol abuse which would interfere with the patient's proper completion of the study.
• •18. Exposure to an investigational product within the last 4 weeks, simultaneous exposure to another investigational product.
• •19. Lack of ability or willingness to give informed consent.
• •20. Anticipated non-availability for study visits / procedures.
• •21. Lack of ability or willingness to keep patient's diary.
• •22. Lack of willingness to have personal study related data collected, archived or transmitted according to the protocol.
• •23. Vulnerable subjects.