Evaluation of the Performance and Safety of an Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and Magnesium Trisilicate (GERDOff® Plus) in Patients With Gastro-Esophageal Reflux Disease: A Double-blind, Placebo-controlled, Randomized, Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Overall patient satisfaction
研究概览
简要总结
This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs.
Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blind, placebo controlled
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent (ICF): a written informed consent must be obtained prior to any study related procedure being performed
- •Male and female out-patients aged 18 to 80 years
- •GERD diagnosis confirmed through a validated questionnaire (GERDQ score ≥ 8).
- •EGD endoscopy performed within 1 year before screening
- •Patients in continuous or intermittent treatment with PPI for at least 1 year and continuously for at least 4 weeks prior to study entry
- •Patients not fully satisfied with current PPI treatment (1-3 score on 5-points Likert scale)
排除标准
- •Dyspeptic patients or patients with overlapping symptoms with GI diseases other than GERD
- •Histological evidence of Barrett's oesophagus > 1 cm in EGD endoscopy
- •Peptic stricture in EGD endoscopy
- •Concurrent findings in the EGD endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator
- •Known impaired kidney or liver function at screening
- •Presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study
- •Medication use (including H2 antagonists, alginates, baclofen, NSAIDS, prokinetics, antidepressants) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study
- •Pregnancy or breast-feeding
- •Females of childbearing potential not employing adequate contraceptive methods
- •Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable)
- •History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent
- •History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
- •Treatment with any investigational drug within the previous 30 days
研究组 & 干预措施
GERDOff Plus
Hyaluronic acid + chondroitin sulphate + magnesium trisilicate melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.
干预措施: Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet (Device)
GERDOff Plus
Hyaluronic acid + chondroitin sulphate + magnesium trisilicate melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.
干预措施: Placebo 1100 mg, identically-looking melt in mouth tablet (Device)
Placebo
Placebo melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for three consecutive weeks. After three weeks of wash-out period, patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.
干预措施: Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet (Device)
Placebo
Placebo melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for three consecutive weeks. After three weeks of wash-out period, patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.
干预措施: Placebo 1100 mg, identically-looking melt in mouth tablet (Device)
结局指标
主要结局
Overall patient satisfaction
时间窗: From baseline to the end of the respective 3-week treatment period
The percentage of patients with an improvement of at least 2 points in the patient satisfaction measured with a 1 to 5 Likert scale (1 worst satisfaction, 5 best satisfaction)
次要结局
- Assessment of palatability(At the end of 3-week treatment period)
- Change of weekly frequency of each symptom using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire(From baseline to the end of the respective 3-week treatment period)
- Evaluation of the intake of rescue medications(From V1 (randomization) to V4 (Day 63 +/- 2 days))
- Change of weekly global score of symptoms using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire(From baseline to the end of the respective 3-week treatment period)
- Change of the intensity of each symptom using the Reflux Symptom Index (RSI) questionnaire(From baseline to the end of the respective 3-week treatment period)
- Change of the global score using the Reflux Symptom Index (RSI) questionnaire(From baseline to the end of the respective 3-week treatment period)