EUCTR2010-021630-63-GB进行中（未招募）不适用
A randomised, double blind placebo controlled study in patients with reflux symptoms to assess suppression of gastro-oesophageal reflux by ‘Gaviscon Double Action Peppermint liquid’ using the BRAVO system - Gaviscon Double Action vs placebo study
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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.Age: = 18 years = 70 years
- •2.Sex: male and female patients were eligible for entry.
- •3.Primary diagnosis: those with self-rated at least moderate heartburn or acid regurgitation within 60 minutes following ingestion of a refluxogenic meal on at least 3 occasions a week at the screening visit.
- •4.Agreement to withhold acid suppressant PPI and H2receptor blocking medications and other medications that affect gastro-intestinal function for 6 days and 3 days respectively prior to the test and during 4 days of monitoring.
- •5.Agreement to withhold antacids or alginate preparations, except those administered as part of study procedures for 1 day prior to the test and during 4 days of monitoring.
- •6.Patients who gave written informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Those with prominent gastrointestinal symptoms or disease other than reflux (including atypical symptoms e.g. cough, sore throat, belching, nausea)
- •2.Those with difficulty swallowing (dysphagia), gastrointestinal bleeding, weight loss (>5% body weight) or other alarm symptoms suggestive of neoplastic or severe inflammatory disease within the last 12 months
- •3.Those with a history or symptoms suggestive of Zollinger-Ellison syndrome, gastric carcinoma, previous or current peptic ulcer disease, pernicious anaemia, Barrett’s oesophagus or systemic sclerosis.
- •4.Those with a history of upper GI surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection
- •5.Those with known hypophosphataemia or phenylketonuria.
- •6.Those with severe constipation or history of colonic stenosis.
- •7.Those with major oesophageal dysmotility on manometry, e.g. achalasia
- •8.Those with severe reflux oesophagitis on endoscopy (LA grade III-IV) or Barrett Oesophagus on endoscopy.
- •9.Those with significant co-morbidity requiring ongoing treatment or investigation
- •10.Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants
- •11.Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment / reduced mobility)
- •12.Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. sexual an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method]. A woman of childbearing potential is defined as any female who has not undergone the menopause or has not had an hysterectomy or surgical sterilisation procedure, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
- •13.Those that do not withhold acid suppressant PPI and H2 receptor blocking medications for 6 days and 3 days respectively prior to the test and during 4 days of monitoring.
- •14.Those that do not withhold antacid or alginate medications for 1 days prior to the test and during 4 days of monitoring (5 days in total)
- •15.Those who have any previous history of allergy or known intolerance to any of the study drugs or following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate, calcium carbonate, carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, peppermint flavour, sodium hydroxide, Placebo: hydrogenated glucose syrup, peppermint flavour, potassium sorbate, methyl paraben, xanthan gum r80, propyl paraben, citric acid.
- •16.Failure to accept or to comply with standard requirements for activity and diet during pH testing as set out in appendix II
- •17.Those unable in the opinion of the Investigator to comply fully with the study requirements.
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