EUCTR2013-004249-17-GB进行中（未招募）1 期
A randomised, placebo controlled trial of extra-oesophageal reflux treatment in the management of upper respiratory symptoms. [TOPPITS: Trial of Proton Pump Inhibitors in Throat Symptoms] - Trial of Proton Pump Inhibitors in Throat Symptoms
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 332
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
- •1. Referred with a persistent (over six weeks) primary throat symptom - globus, hoarseness, throat clearing, throat discomfort, choking spasms, excess mucus/postnasal drip.
- •2. Informed consent to participate in entry screen.
- •3. Score over 10 on the non-heartburn items of the Respiratory Symptoms Index.
- •4. Patient has provided written informed consent for participation in the study prior to any study-specific procedures after reading the appropriate information and the required cooling off period has ensued.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 249
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 83
排除标准
- •Those with an RSI score excluding the lower GI item of <10.
- •Patients who are not willing to undergo flexible endoscopy could not by definition be included.
- •Inability to complete the relevant questionnaires.
- •Patients under 18 years old.
- •Endoscopic evidence of specific laryngopharyngeal pathology that would ordinarily be treated by surgical intervention or be investigated by specific investigations. This would include suspected neoplasia/dysplasia, prominent Reinke's oedema or unilateral vocal fold polyp, vocal cord palsy and rarities such as amyloid, Wegener's, sarcoid.
- •Confirmed or likely, current or prior malignancy of head and neck or oesophagus.
- •Performing voice user.
- •Pregnant or lactating woman. Woman of child bearing potential must be using adequate contraception.
- •Currently on acid suppressant, acid neutralisers and alginates and unwilling to discontinue for 4 weeks pre study washout period.
- •Prior adverse reaction to proton pump inhibitor.
- •Severe hepatic dysfunction.
- •Patients taking clopidogrel or Warfarin.
- •Patients taking Phenytoin.
- •Patients taking systemic antifungal treatment (specifically itraconazole, ketoconazole, posaconazole and voriconazole).
- •HIV positive/Patients taking Antiviral medications (atazanavir, nelfinavir, raltegravir, saquinavir, tipranavir).
- •Patients taking digoxin, cyclosporine, methotrexate, erlotinib, lapatinib, tacrolimus, sucralfate, escitalopram, fluvoxamine, St Johns wort, clozapine, Ulipristal or Cilostazol.
- •Previous participation in this study.
- •Use of other investigational study drugs within 30 days prior to study entry.
研究者
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