EUCTR2014-005261-69-IT进行中（未招募）1 期
A multi-centre, randomized, double-blind, two arm, parallel group, placebo-controlled study to assess the effect of Sodium Alginate Chewable Tablets on syntoms of gastro-oesophageal reflux disease - Sodium Alginate Chewable Tablet European Symptom Relief Study
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
- 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
- 性别
- All
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
- •*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
- •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 329
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 164
排除标准
- •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
- •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. Known 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 medications (in
- •the periods specified below), and those not willing / unable to withhold
- •them throughout the study:
- •i. Macrolide antibiotics (e.g. erythromycin and azithromycin) within 24
- •hours before screening (Visit 1)
- •ii. Antacids and alginate preparations within 24 hours before
- •randomisation
- •iii. Patients who have taken Proton Pump Inhibitors (PPIs) within the 10
- •days prior to randomisation (Visit 2), prokinetics or H2 antagonists
- •within the 5 days prior to randomisation (Visit 2) or systemic
- 另有 2 项未显示
研究者
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