Evaluation of the Effects of GERDOFF in Combination With a 6-week Therapy Based on Proton Pump Inhibitors Versus Proton Pump Inhibitors Alone on GERD-high Symptoms in Patients With Primary Diagnosis of Gastroesophageal Reflux Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
研究概览
简要总结
The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms.
The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.
详细描述
Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. These disorders may represent extra-esophageal manifestations of gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been proved as useful to improve patients' quality of life.
The aim of the present study was to evaluate, in first diagnosed patients presenting with upper symptoms associated with GERD, the effect of a 6-week treatment with a combination based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated with the combination of the two products, the reduction in symptoms frequency by means of a Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients included in the two groups were then classified as responders or non-responders. Responder patients were defined as those patients that, at the 6th week of treatment, reached a RSI score decreased for at least 50% compared to baseline and an absolute value < 13.
Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was evaluated after a period of follow-up lasting 12 weeks, which could be entered only by responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up period were randomised to receive Gerdoff® or no treatment (control group). Safety data were also evaluated in the group of patients that continued in the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 18 years;
- •First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
- •Presence of extra-oesophageal symptoms associated with GERD;
- •RSI score ≥ 20;
- •Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
- •Cooperative patients, able to understand and adhere to the study procedures;
- •Patient able to freely give their written informed consent to study participation;
- •Patients that freely gave the consent to management of personal data related to the study.
排除标准
- •Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
- •Acute or chronic rhinosinusitis;
- •Chronic bronchitis;
- •Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
- •Ongoing neoplasias;
- •Uncontrolled diabetes;
- •Patients with impaired liver function;
- •Patients with rare hereditary problems of galactose intolerance;
- •Patients that, based on Investigator's opinion, could not take part in the study due to other diseases or concomitant therapies, such as the intake of atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of Product Characteristics of Gerdoff®);
- •Patients with deficiency of Lapp lactase;
- •Patients with syndrome of glu-gal malabsorption;
- •Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;
- •Patients already in treatment with PPIs or similar products;
- •Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);
- •Abuse of drug or alcohol;
- •Inability of the subject to adequately express his/her disturbances;
- •Patients with planned or ascertained pregnancy or that did not adopt an accepted contraceptive method;
- •Lactating patients.
研究组 & 干预措施
GERDOFF® + omeprazole
GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
干预措施: GERDOFF® + Omeprazole (Device)
Omeprazole
Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
干预措施: Omeprazole (Drug)
结局指标
主要结局
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
时间窗: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)
After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).
次要结局
- Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4(At baseline and in the visit 4)
- Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed(In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment))
- Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4(At baseline and in the visit 4, after 6 weeks of treatment)
- Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance(At baseline and in the visit 4, after 6 weeks of treatment)
- Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4(At baseline and in the visit 4, after 6 weeks of treatment)
- Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4(At baseline and in the visit 4, after 6 weeks of treatment)
- Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying(At baseline and in the visit 4, after 6 weeks of treatment)
- Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4(At baseline and in the visit 4, after 6 weeks of treatment)
- Use of Rescue Medication (Omeprazole) During the Treatment(From baseline to visit 4)
- Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4(At baseline and in the visit 4, after 6 weeks of treatment)
- Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4(At baseline and in the visit 4, after 6 weeks of treatment)
- Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4(At baseline and in the visit 4, after 6 weeks of treatment)
- Number of Responders V4(At visit 4 after 6 weeks of treatment)
- Number of Responders V6(In the Visit 6 at the end of follow-up)
- Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire(At visit 4 after weeks of treatment)
- Use of Rescue Medication (Omeprazole) During the Follow-up(In the Visit 6 after 12 weeks from baseline)
- Use of Rescue Medication (Other Than Omeprazole) During Treatment(From baseline to visit 4)
- Patients'Satisfaction(At visit 4 after weeks of treatment)