EUCTR2014-005261-69-GB进行中（未招募）1 期
A multi-centre, randomised, double-blind, two arm, parallel group, placebo-controlled study to assess the effect of Sodium Alginate Chewable Tablets on symptoms of gastro-oesophageal reflux disease. - Sodium Alginate Chewable Tablet European Symptom Relief Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 424
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. Informed consent has been freely given.
- •2. Males and females = 18 years.
- •3. Primary diagnosis: Current documented evidence of symptomatic GORD in accordance with the Montreal definition. This evidence can be based solely on symptom characteristics. Patients must have experienced frequent troublesome heartburn and / or regurgitation (with or without dyspepsia symptoms) of at least moderate intensity* during the last 3 months and also on at least five days during the week before the start of screening. If the patient also has other symptoms, the heartburn, regurgitation or dyspepsia should be the predominant symptoms.
- •*Symptom intensity should be assessed using the following scale:
- •I. Mild: awareness of symptom but easily tolerated
- •II. Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep
- •III. Severe: incapacitating symptom with inability to perform normal activities, including sleep
- •4. At Visit 2, all 12 items of the RDQ are to be completed with a minimum score of 1.5 for heartburn recorded.
- •5. Status: Patients may be referred from either their General Practitioner (GP) / consultant or by attending the investigational site, without GP referral, in response to an advertisement to join this clinical study. In addition patients may be recruited by the clinic from hospital databases or out-patient clinics.
- •6. Patients must be sufficiently literate to be able to complete the RDQ unaided.
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
排除标准
- •Patients to whom any of the following conditions apply must be excluded:
- •1. Those who have a current or recent (within one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances or solvents.
- •2. Patients with a history and / or symptom profile indicative of severe diseases of major body systems.
- •3. Patients either with any co-existing condition which, in the opinion of the Investigator, would be likely to compromise patient safety or interfere with assessment of efficacy;
- •or with any clinically significant abnormal laboratory values.
- •4. Patients presenting with a history of psychiatric diagnosis according to Chapter V International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)-2015-WHO.
- •5. Presence of clinically significant abnormalities in the physical examination, endoscopy, ECG, vital signs, and laboratory safety results.
- •6. Patients who have suffered cardiac chest pain within the last year.
- •7. Patients with documented damaged heart or severe / impaired kidney function or insufficiency and patients who require a low sodium diet.
- •8. Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
- •9. Patients who have suffered a recent, significant, unexplained weight loss of more than 7 Kg in the last 6 months.
- •10. Those with difficulty swallowing (dysphagia), gastrointestinal (GI) bleeding, or other symptoms suggestive of neoplastic or severe inflammatory disease within the 12 months before screening (Visit 1).
- •11. Patients with a history (within the last 3 months) and / or symptom profile suggestive of and / or discovered on endoscopy of the following:
- •i. Gastric or duodenal erosions
- •ii. Duodenitis
- •iii. Polyps larger than 0.5 cm, or those clinically significant in the opinion of the Investigator
- •iv. Erosive GORD (Los Angeles [LA] classification grades C-D)
- •v. Barrett’s oesophagus
- •vi. Acute peptic ulcer and / or ulcer complications
- •vii. Zollinger-Ellison syndrome
- •viii. Gastric carcinoma
- •ix. Pyloric stenosis
- •x. Patients who were observed on endoscopy to have a hiatus hernia with a diameter which exceeds 3cm
- •xi. Any other clinically significant gastrointestinal disease
- •12. Oesophageal or gastric surgery, intestinal obstruction.
- •13. Current pernicious anaemia.
- •14. Indication for H-pylori eradication therapy.
- •15. Known gastro-intestinal bleeding (haematochezia or haematemesis).
- •16. Those with a history of upper GI surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection.
- •17. Patients with severe constipation.
- •18. Any previous history of allergy or known intolerance to 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.
- •19. Patients who have taken any of the below prohibited med
研究者
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