EUCTR2012-004109-28-GB进行中（未招募）1 期
A randomised, 4 way crossover, double blind, placebo controlled pilot study in patients with reflux symptoms, to assess suppression of gastro-oesophageal reflux by ‘Gaviscon Double Action Mint ’ using the Bravo system
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
- 28
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
入选标准
- •1.Age: = 18 years = 70 years.
- •2.Sex: male and female patients.
- •3.Patients referred to secondary care for further investigation of typical reflux symptoms (heartburn and/or acid regurgitation). Patients must have been referred to secondary care within 2 years of the start of the study. Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity* on at least three days a week during the two weeks before the start of screening. If the patient also has other symptoms, the heartburn or regurgitation must be the predominant symptoms. Patients must be symptomatic when withholding prescribed medication for reflux disease.
- •*Symptom intensity should be assessed using the following scale;
- •Mild: awareness of symptom but easily tolerated
- •Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep
- •Severe: incapacitating symptom with inability to perform normal activities, including sleep
- •4.No major esophageal dysmotility (i.e. achalasia, esophageal spasm / hypertensive dysmotility, aperistalsis) or presence of hiatus hernia >3 cm on Oesophageal Manometry or High Resolution Manometry (HiRM)
- •5.Agreement to withhold acid suppressant PPI and H2 receptor blocking medications and other medications that affect gastro-intestinal function (e.g macrolide antibiotics such as erythromycin and azithromycin, and 5HT agonists such as sumatriptan) for 2 weeks prior to the start of the study and throughout the treatment periods.
- •6.Agreement to withhold antacids or alginate preparations, except those administered as part of study procedures for 1 day prior to the start of the study and throughout the treatment periods.
- •7.Patients who give 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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
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 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 Gastrointestinal (GI) surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection.
- •5.Those with known hypophosphataemia.
- •6.Those with severe constipation or history of colonic stenosis.
- •7.Those with major oesophageal dysmotility e.g. achalasia, or with hiatus hernia >3 cm on manometry.
- •8.Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants (including anti-platelet drugs).
- •9.Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment / reduced mobility).
- •10.Those on a highly restricted salt diet.
- •11.Those with, or a history of, hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
- •12.Those with clinically abnormal laboratory assessments at screening. Repeat laboratory assessments will not be performed.
- •13.Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
- •14.Pregnancy or lactating mother.
- •15.Those who have already participated in the study, including the validation phase.
- •16.Those who are an employee at the study site.
- •17.Partner or first-degree relative of the Investigator.
- •18.Any previous history of allergy or known intolerance to any constituents of the IMP, including: sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer and xanthan gum.
- •19.Failure to accept or to comply with standard requirements for activity and diet during pH testing as set out in the patient diary.
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