NCT01336530终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 32
- 主要终点
- Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
研究概览
简要总结
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.
详细描述
Tepilta® Suspension is indicated for treatment of pain in the upper digestive system induced by radiation therapy, in particular for radiation-induced oesophagitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Oesophageal symptoms of grade ≤ 2a according to the adapted Common Terminology Criteria for Adverse Events CTCAE.
排除标准
- •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.
- •Known bone metastases.
- •Reflux oesophagitis 3 months prior to the study.
- •Continuous systemic pain treatment at the beginning of RT. Systemic pain medication for oesophagitis prior to randomisation must not be taken.
- •Concomitant treatment with tetracyclines, cinolone derivatives (ciprofloxacin, ofloxacin, enoxacin, norfloxacin), cheno-desoxycholic acid, sodium fluoride, local anaesthetics (other than those used as study medication).
- •Patients relying on levothyroxine after resection of thyroid carcinoma being hypothyroid and patients relying on levothyroxine due to other reasons not being euthyroid.
- •Artificial nutrition at the beginning of radiation.
- •Drug (licit and illicit) or alcohol abuse which would interfere with the patient's proper completion of the study.
- •Exposure to an investigational product within the last 4 weeks, simultaneous exposure to another investigational product.
- •Lack of ability or willingness to give informed consent.
- •Anticipated non-availability for study visits / procedures.
- •Lack of ability or willingness to keep patient's diary.
- •Lack of willingness to have personal study related data collected, archived or transmitted according to the protocol.
- •Vulnerable subjects.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Vehicle (Other)
Tepilta®
Experimental
干预措施: oxetacaine, aluminium and magnesium hydroxide (Drug)
Oxetacaine
Active Comparator
干预措施: oxetacaine (Drug)
Antacids
Active Comparator
干预措施: magnesium and aluminium hydroxide (Drug)
结局指标
主要结局
Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO).
时间窗: up to 11 weeks
次要结局
- 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)
研究者
研究点 (32)
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