Tepilta® Versus Oxetacaine, Antacids and Placebo (NCT01336530) | Clinical Trial Compass
TerminatedPhase 3
Tepilta® Versus Oxetacaine, Antacids and Placebo
Stopped: The study stopped prematurely due to and administrative reasons, not based on grounds of safety.
Austria, Germany40 participantsStarted 2011-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✓. Appearance of oesophageal pain as follows: Score ≥ 2 on Numeric Rating Scale (NRS) for pain during main daily meals is reached at least once.
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).
What they're measuring
1
Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
✕. 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).