EUCTR2009-014441-93-DE进行中（未招募）1 期
Clinical trial to assess the efficacy of the fixed combination product Tepilta® in the treatment of radiation-induced oesophagitis compared to its active ingredients oxetacaine and antacids, and to placebo - Tepilta® vs. oxetacaine, antacids and placebo
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 810
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
- •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 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).
研究者
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