EUCTR2012-002188-84-GB进行中（未招募）不适用
A multi-centred, randomised, double-blind, two arm, parallel group, placebo-controlled, pilot study to assess the effect of Gaviscon Double Action Tablets in patients with reflux disease - Gaviscon Double Action Tablets Pilot Efficacy Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Only subjects to whom all of the following conditions apply will be included:
- •1.Informed consent has been obtained.
- •2.Age: = 18 years.
- •3.Sex: male or female.
- •4.GERD status: history of frequent episodes of GERD-related symptoms during the last 3 months and also during the 5 days of the last 7 days prior to study screening.
- •5.Subjects who have not taken any antacids within 24 hours before randomisation (Visit 2) and be instructed not to take antacids throughout the remainder of the study.
- •6.Subjects taking mucous membrane protection drugs or motility stimulants may enter the study provided that these are discontinued for at least 3 days before enrolment and throughout the remainder of the study.
- •7.Absence of relevant abnormalities in the physical examination, ECG and safety analysis.
- •8.Subjects must be sufficiently literate to be able to complete the RDQ unaided.
- •9. Status: subjects will be members of the public who respond to an advertisement or via their doctor.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •Subjects to whom any of the following conditions apply must be excluded:
- •1)Subjects who have a history of drug, solvent or alcohol abuse (weekly alcohol intake = 140g or 17.5 units).
- •2)Subjects who have suffered cardiac chest pain within the last year.
- •3)Subjects who have suffered a recent, significant unexplained weight loss of more than 6 Kg in the last 6 months.
- •4)Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions (as defined in Section 10.3) or are unwilling to be sexually abstinent.
- •5)Pregnancy or lactating mother.
- •6)Subjects with a history and/or symptom profile suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades A-D), Barrett’s oesophagus, acute peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, indication for H-pylori eradiation therapy, requirement for low sodium diet, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.
- •7)Subjects who have taken PPIs during the 10 days prior to study start, prokinetics or H2 antagonists during the 5 days prior to study start or systemic glucocorticosteroids, anti-inflammatory drugs on more than 3 consecutive days or PPI-based triple therapy for eradication of H-pylori during the last 28 days.
- •8)Subjects with known hypophosphataemia or phenylketonuria.
- •9)Subjects with severe constipation, or history of intestinal obstruction.
- •10)In the opinion of the Investigator, subjects with damaged heart or kidney function and subjects who require a low sodium diet.
- •11)Subjects either with any co-existing condition which, in the opinion of the Investigator, would be likely to compromise subject safety or interfere with assessment of efficacy; or with any clinically significant abnormal laboratory values; or in the Investigator’s view to unable to comply fully with the study requirements.
- •12)Subjects with severe/impaired renal function or insufficiency
- •13)Any previous history of allergy or known intolerance to any of the IMP’s or following formulation constituents: macrogol 20,000, mannitol (E421), copovidone, acesulfame K, aspartame (E951), mint flavour, carmoisine lake (E122), magnesium stearate, xylitol DC (contains carmellose sodium) or the following formulation constituents: sodium alginate, calcium carbonate, sodium bicarbonate.
- •14)Previously randomised into the study.
- •15)Employee at study site.
- •16)Partner or first-degree relative of the Investigator.
- •17)Participation in a clinical study in the previous 6 months.
- •18)Unable in the opinion of the Investigator to comply fully with the study requirements.
研究者
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