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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
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
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).
Device: GERDOFF®
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).
Drug: Omeprazole
Omeprazole, 2 tablets 20 mg, once a day before breakfast
Other Name: Omeprazen




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. both females and males
  2. age> 18 years
  3. first diagnosis of GERD with high symptoms, based on clinical evaluation and confirmed by otolaryngologic and/ or gastroenterological examination with reflux symptoms index questionnaire
  4. presence of extra-oesophageal symptoms associated with GERD
  5. RSI score ≥ 20
  6. patients who are not pre-treated with proton pump inhibitors, also for conditions different from GERD, and/ or medical devices, and/ or similar products (i.e. alginates) during the last 4 weeks.
  7. patients able to understand and follow the study procedures
  8. patients able to sign the informed consent for study participation and for personal data treatment.

Exclusion Criteria:

  1. known infectious esophagitis
  2. chronic and acute rhinosinusitis
  3. chronic bronchitis
  4. known Zollinger-Ellison syndrome, hiatal hernia >3 cm and Barret oesophagus
  5. ongoing cancers
  6. uncontrolled diabetes
  7. compromised hepatic function
  8. hereditary galactose intolerance
  9. patients who cannot participate based on clinical judgement due to the presence of other disease or concomitant therapies with atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib
  10. Lapp lactase deficit
  11. Glu-Gal malabsorption
  12. hyper-sensibility to omeprazole, benzamydolic substitutes or any other excipients
  13. ongoing treatment with proton pump inhibitors or similar products.
  14. chronic use of drug interfering with salivation (i.e. anti-histaminic or inhaled steroids)
  15. alcohol and drug abuse
  16. subjects who are not able to adequately explain their symptoms
  17. women with planned or confirmed pregnancy or who are not using an acceptable contraception method
  18. breastfeeding women
  19. subjects not willing to consent personal data treatment.

Information from the National Library of Medicine

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


Locations
Italy
dr Alessandro Repici
Rozzano, MI, Italy, 20089
Sponsors and Collaborators
SOFAR S.p.A.
Investigators
Principal Investigator: Alessandro Repici, MD Istituto Clinico Humanitas

Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov Identifier: NCT03793556     History of Changes
Other Study ID Numbers: PSC-DS GERD AP 16
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Omeprazole
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action