EUCTR2011-005486-21-DE进行中（未招募）不适用
A multicentre, randomised, double-blind, two arm, parallel group, placebo controlled, pilot study to assess the effect of Gaviscon Advance as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.
适应症
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
- 150
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) Male or female patients aged at least 18 years.
- •2) Evidence of symptomatic GORD, despite current treatment with the optimum individualized dose of a once daily proton pump inhibitor. GORD symptoms should be such that the Investigator believes it is likely that the patient will achieve a score of 18 during one week of treatment with a PPI before randomization (as described in Section 10.3: Additional Inclusion Criteria for Randomisation, number 2).
- •3) Treatment with once daily PPI for at least the previous 4 weeks.
- •4) Compliance regarding use of prescribed once-daily PPI over 4 weeks, as determined by the investigator.
- •5) Provision of written informed consent.
- •Additional Inclusion Criteria for Randomisation
- •Following the 7-day run in period, patients will be assessed against the following inclusion criteria before randomisation.
- •1) Completion of the run-in diary card and questionnaires on each of the seven days of the run-in period.
- •2) At least one reflux symptom (heartburn or regurgitation) of at least moderate intensity measured during the 7-day run-in period (from the HRDQ questionnaire) and a summarised 7-day score of at least 18 (e.g. corresponding to 3 days with moderate heartburn 3 times a day). (The daily score will be calculated as intensity x frequency, where intensity is scored as 0 = none, 1 = mild, 2 =
- •moderate and 3 = severe and frequency is scored as 0 = none, 1 = once, 2 = twice, 3 = thrice, 4 = 4 or 5 times, 5 = 6 – 10 times and 6 = more than 10 times or constant).
- •3) Compliance with PPI treatment (once daily in the morning) on all seven days of the run-in period.
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1) Oesophageal stricture, peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, recent upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
- •2) Drug, solvent or alcohol abuse (weekly alcohol intake = 140g) within the 3 months before screening.
- •3) Cardiac chest pain within the 3 months before screening.
- •4) Recent, significant unexplained weight loss of greater than 6 kg in the last 6 months.
- •5) Gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months.
- •6) Allergy or known intolerance to any of the study drug excipients: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, fennel flavour and sodium hydroxide, or the following formulation constituents:
- •sodium alginate, calcium carbonate, potassium bicarbonate, methyl titanium dioxide and xanthan gum.
- •7) Use of antidepressants, non-steroidal anti-inflammatory drugs or other analgesics that might, in the opinion of the investigator, compromise symptom recording.
- •8) Current enrollment in another study or involvement in a previous symptom relief Gaviscon study.
- •9) Previous surgery of the oesophagus, stomach or duodenum.
- •10)History of hypercalcaemia or nephrocalcinosis.
- •11) Potential language problems in understanding information and recording symptoms.
- •12) Pregnancy or breast feeding.
- •13) Any co-existing condition which, in the opinion of the investigator, would be likely to compromise patient safety or interfere with the assessment of efficacy.
研究者
相似试验
进行中（未招募）
不适用
Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to PPI treatmentPatients with Gastro Oesophageal Reflux Disease (GORD) with inadequate response to PPI treatmentEUCTR2012-004470-25-GBReckitt Benckiser Healthcare (UK) Ltd
进行中（未招募）
1 期
Study to assess the effect of Gaviscon Advance as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.Gastro Oesophageal Reflux Disease (GORD)MedDRA version: 15.1Level: LLTClassification code 10066874Term: Gastroesophageal reflux diseaseSystem Organ Class: 100000004856EUCTR2011-005486-21-DKReckitt Benckiser Healthcare (UK) Ltd.150
进行中（未招募）
1 期
Sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to PPI treatment – a pivotal study.EUCTR2014-003174-17-GBReckitt Benckiser Healthcare (UK) Limited396
进行中（未招募）
1 期
Sodium Alginate Chewable Tablet European Symptom Relief Study for patients with symptoms of GORDEUCTR2014-005261-69-DEReckitt Benckiser Healthcare (UK) Limited493
进行中（未招募）
1 期
Sodium Alginate Chewable Tablet European Symptom Relief Study for patients with symptoms of GORDEUCTR2014-005261-69-GBReckitt Benckiser Healthcare (UK) Limited424