Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor
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|ClinicalTrials.gov Identifier: NCT03793556|
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
The aim of the present study is to evaluate the effect of a 6-weeks treatment of a 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 will verify 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 we will evaluate the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients
|Condition or disease||Intervention/treatment||Phase|
|Gastro-oesophageal Reflux Disease||Device: GERDOFF® Drug: Omeprazole||Not Applicable|
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 is to evaluate the effect of treatment for 6 weeks with a preparation based on chondroitin sulfate, hyaluronic acid and aluminum hydroxide (GERDOFF®), combined with a treatment with inhibitors of the proton pump (PPI) only in patients presenting associated extra-esophageal symptoms to gastroesophageal reflux disease (GERD) in first diagnosis.
The investigators will evaluate the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the RSI questionnaire (Reflux Symptom Index), in patients with the association and to evaluate Responders and Non-Responder patients in these two groups after 6 weeks of treatment compared to baseline.
After 12-week follow-up, the investigators will evaluate the persistence of effects of GERDOFF® + PPI on extraesophageal symptoms, only in responder patients (enrolled in the arm GERDOFF + PPI) who have reached an RSI score lower at least 50% than baseline and an absolute value <13. Patients who will be included in the follow-up will be randomized in the GERDOFF® group or in the control group (no treatment).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized in ratio 1:1 and treated with the investigational drug or an active comparator for 6 weeks. At the end of treatment visit (V4) only patients who will be classified as responders and belonging to the GERDOFF®+PPI group will be included in the follow-up phase for 12 further weeks. During the follow-up, patients will be randomized to 1:1 ratio to GERDOFF® group or control group that will not receive any treatment for 12 weeks in order to evaluate the maintenance of treatment effects.|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||May 5, 2017|
|Actual Primary Completion Date :||September 20, 2018|
|Actual Study Completion Date :||December 11, 2018|
Experimental: GERDOFF® + omeprazole
GERDOFF® (tablets) will be orally administered 3 times per day after meals; omeprazole will be orally administered once a day before breakfast (2 tablets). The treatment will last 6 weeks (+/- 2 days).
GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg
Active Comparator: Omeprazole
Omeprazole will be orally administered once a day before breakfast (2 tablets). The treatment will last 6 weeks (+/- 2 days).
Omeprazole, 2 tablets 20 mg, once a day before breakfast
Other Name: Omeprazen
- Improvement of high symptoms of GERDOFF + omeprazole versus omeprazole [ Time Frame: 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 Index Symptoms questionnaire will be evaluated to verify the effects of treatments on high symptoms.
- Reduction of symptoms frequency [ Time Frame: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment) ]Reduction of symptoms frequency after 6 weeks of treatment, evaluated by the Likert scale
- Number of responders after 6 weeks of treatment [ Time Frame: In the visit 4, after 6 weeks of treatment ]Number of patients randomized in the group GERDOFF + PPI and who respond to treatment
- Percentage of responders after 6 weeks of treatment [ Time Frame: In the visit 4, after 6 weeks of treatment ]Percentage of patients randomized in the group GERDOFF + PPI and who respond to treatment
- Number of responders after the 12-week follow-up [ Time Frame: In the visit 6 (after the12-week follow-up) ]Number of Responder patients previously randomized in the group GERDOFF + PPI who maintain a symptoms improvement throughout the study.
- Percentage of responders after the 12-week follow-up [ Time Frame: In the visit 6 (after the12-week follow-up) ]Percentage of Responder patients previously randomized in the group GERDOFF + PPI who maintain a symptoms improvement throughout the study.
- Adverse events (AE) [ Time Frame: During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI ]Evaluation of incidence and severity of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793556
|dr Alessandro Repici|
|Rozzano, MI, Italy, 20089|
|Principal Investigator:||Alessandro Repici, MD||Istituto Clinico Humanitas|