CTRI/2024/02/062711招募中4 期
Prospective, non-interventional, multi-centre, post marketing surveillance study to evaluate the safety and tolerability of Gaviscon Double Action Oral Suspension and Gaviscon Double Action Tablets for the management of symptoms of gastroesophageal reflux disease - DAPI
Reckitt Benckiser Healthcare0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patient is willing to provide informed consent and able to comply with all study requirements, including attendance at follow-up visits
- •2. Patient is male or female and aged: = 18 years of age.
- •3. Within the previous 24 hours, patient has been prescribed Gaviscon Double Action Oral Suspension or Tablets for the treatment of reflux related symptoms in line with the marketing authorisation
- •4. Patient has experienced reflux related symptoms (such as heartburn and/or regurgitation) within the 48-hour period prior the screening visit and on at least two other days within the week before screening.
排除标准
- •1. Patient with any previous history of allergy or known intolerance to any of the ingredients in the formulations including, Sodium alginate, Sodium bicarbonate, Calcium carbonate or hydroxybenzoate (parabens) and excipients.
- •2. Except for the previous 24 hours, patient has taken Gaviscon Double Action Oral Suspension or Tablets in the past 12 weeks.
- •3. Patients with any co-existing condition or taking medication which, in the opinion of the Investigator, would be likely to compromise patient safety. In particular, caution should be exerted for patients with hypertension, renal or cardiac failure, oedema or hypercalcemia. In addition, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxin, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, diphosphonates, and estramustine.
- •4. Patient has received an investigational product or participated in another trial involving a marketed or investigational drug in the 90 days prior to screening.
- •5. Patient, in the opinion of the Investigator, is unable to comply fully with the study requirements.
- •6. Patient who is an employee at the site or a partner or first-degree relative of the Investigator.
- •7. Patient has been previously enrolled in this study.
- •8. Patient fails to satisfy the investigator of fitness to participate for any other reason.
研究者
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