Radiation-induced oesophagitis MedDRA version: 19.1 Level: PT Classification code 10048899 Term: Radiation oesophagitis System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Tepilta suspension
Pharmaceutical Form: Oral suspension
Other descriptive name: Aluminium hydroxide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 582-
Sponsors
MEDA Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Screening Criteria: 1. Male or female = 18 years 2. Score = 0 on NRS for oesophageal pain. 3. 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. 4. Duration of radiotherapy 5 to 8 weeks. 5. 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). 6. First radiation in the intended radiation area. 7. Written informed consent. Randomisation criteria: 8. Appearance of oesophageal pain (not tumour-induced) as follows: Score = 2 on Numeric Rating Scale (NRS) for pain during main daily meals is reached at least once. 9. At least 20 Gy of the dose of radiation therapy in oesophageal area remaining. 10. Oesophageal symptoms of grade = 2a according to the adapted Common Terminology Criteria for Adverse Events CTCAE for oesophagitis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 405 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 405
Exclusion criteria
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. Women of child bearing potential not using highly effective methods of birth control defined as those which result in a low failure rate (i.e. 60% of total intended radiation dose at the swallowing organs (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 (from medical history). 13. Continuous systemic pain treatment at the beginning of RT. Systemic pain medication for oesophagitis prior to randomisation must not be taken. Temporary intake of systemic non-oesophageal pain medication prior to randomisation is allowed as judged by the investigator. However, 3 days before randomisation systemic non-oesophageal pain medication must not be taken. 14. Concomitant treatment with tetracyclines, chinolone derivatives (ciprofloxacine, ofloxacine, enoxacine, norfloxacine), 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 levothyroxin due to other reasons not being euthyroid. 16. Artificial nutrition at the beginning of radiation (artificial nutrition defined as infusions of fats, trace minerals, protein, vitamins, and high-dose carbohydrates by indwelling venous cannulas, PEG tubes, CVCs (central venous catheters) or ports. Artificial nutrition is not meant as infusions of fluid, electrolytes or glucose.). 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 (such as persons kept in detention).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: • To prove the combination effect of oxetacaine and antacids, i.e. to demonstrate superior efficacy of Tepilta® versus oxetacaine, antacids, and placebo. ;Secondary Objective: Secondary objectives: • To further evaluate safety of Tepilta®.;Primary end point(s): Efficacy: ASPO: Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO). ;Timepoint(s) of evaluation of this end point: First interim analysis around 2013, second interim analysis around 2014/2015, final analysis around 2016 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: ASPO: WHO analgesic pain ladder; Pain intensity (oesophageal pain during main meals of the day) recorded on NRS with scores 0 to 10; Swallowing disorder recorded on NRS with scores 0 to 10; Adapted CTCAE grade for oesophagitis; Incidence of artificial nutrition due to radiation-induced oesophagitis; Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis; Duration of pain medication intake after the end of RT (in days); Loss of body weight; Global assessment of efficacy by investigator. Safety: Adverse events. Global assessment of safety by investigator.;Timepoint(s) of evaluation of this end point: First interim analysis around 2013, second interim analysis around 2014/2015, final analysis around 2018 | — |
Countries
Austria, Germany
Contacts
Public ContactDepartm. Corporate Clinical Affairs
MEDA Pharma GmbH & Co. KG
Outcome results
None listed