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Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

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ClinicalTrials.gov Identifier: NCT03883074
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.

Brief Summary:
The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.

Condition or disease Intervention/treatment Phase
Gastro Esophageal Reflux Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicate Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Combination Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and With Magnesium Trisilicate on Mucosal Integrity and Reflux Exposure in Subjects With Gastro-Esophageal Reflux Disease Not Currently Treated With a Proton Pump Inhibitor: a Double-Blind, Placebo-Controlled, Randomized, Crossover Study
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020


Arm Intervention/treatment
Experimental: GERDOff® Plus
hyaluronic acid with 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.
Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicate
Melt in mouth tablets (1100 mg)
Other Name: GERDOff Plus

Placebo Comparator: 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.
Device: Placebo
tablets with the same aspect of the active device
Other Name: Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)




Primary Outcome Measures :
  1. Esophageal Impedance [ Time Frame: 3 weeks ]
    Change between groups in baseline impedance value. Impedance baseline values will be assessed in two steady periods of 30 seconds at the beginning and at the end of consecutive time windows of 30 minutes, 60 minutes.


Secondary Outcome Measures :
  1. Esophageal acid exposure [ Time Frame: 3 weeks ]
    Esophageal acid exposure assessed by 24-hour pH-impedance measurement

  2. Esophageal permeability [ Time Frame: 3 weeks ]
    Esophageal permeability assessed by transepithelial electrical resistance

  3. Microscopic esophagitis [ Time Frame: 3 weeks ]
    Microscopic esophagitis evidence at endoscopy assessed by Esohisto score. The score assesses the severity of esophagitis through a score for each parameter ranging from 0 to 2 (0=normal, 2=severe). Parameters are: Basal cell layer hyperplasia; Papillary elongation; Dilated intercellular spaces; Intraepithelial eosinophils; Intraepithelial neutrophils; Intraepithelial mononuclear cells

  4. Intercellular spaces [ Time Frame: 3 weeks ]
    The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy.

  5. The expression of tight junctions [ Time Frame: 3 weeks ]
    The expression of tight junction proteins at RNA, protein and immunohistochemistry level

  6. ReQuest Questionnaire score [ Time Frame: 3 weeks ]
    Change in ReQuest score for GERD symptoms severity evaluated through ReQuest Questionnaire. ReQuest is a self-assessed, dimension-orientated scale designed to evaluate the treatment response in patients suffering from erosive GERD. It assesses seven dimensions of GERD (acid complaints, upper abdominal/stomach complaints, lower abdominal/ digestive complaints, nausea, sleep disturbances, other complaints and general well-being). The intensity is measured on a 100-mm visual analogue scale and the frequency (except general well-being) on a 7-point Likert scale, ranging from 0 to more than 10 times per day. It asks for the occurrence of symptom descriptions known to be typical of the corresponding dimension

  7. Esophageal reflux episodes [ Time Frame: 3 weeks ]
    Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, age 18 to 75 years
  • GERD as defined by an acid exposure time >4% on pH/impedance monitoring and/or esophagitis LA grade A or B on endoscopy
  • Heartburn at least twice per week over the last 1 month
  • ReQuest Symptoms sum score >3,37 at screening
  • GERD patients not treated with a PPI in the previous 2 months
  • Subjects capable of understanding and be willing to provide signed and dated written voluntary informed consent

Exclusion Criteria:

  • Patients suffering from gastrointestinal diseases other than GERD

    • Esophagitis LA grade C or D or Barrett's esophagus on endoscopy
    • Impaired kidney or liver function
    • Significant cardiac, pulmonary or psychiatric comorbidity as judged by the investigator
    • Medication use (including NSAIDS) 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 in the absence of effective contraceptive methods
    • 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
    • Active malignancy of any type, or history of cancer, including solid tumors and hematological malignancies (except patients with malignancies that have been surgically removed and/or with no evidence of recurrence for at least five years before study enrolment)
    • Inability to conform to protocol procedures

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): NCT03883074


Contacts
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Contact: Silvia Porta +39 02909231 silvia.porta@sofarfarm.it
Contact: Francesca Baldan +39 02909231 francesca.baldan@sofarfarm.it

Locations
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Belgium
UZLeuven Recruiting
Leuven, Belgium, box 701, 3000
Contact: Jan Tack, Prof.    +32 (0)16 345514    jan.tack@kuleuven.be   
Sponsors and Collaborators
SOFAR S.p.A.
Investigators
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Principal Investigator: Jan Tack, Prof. Universitaire Ziekenhuizen Leuven

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Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov Identifier: NCT03883074     History of Changes
Other Study ID Numbers: PSC-DS TRIGERD 18
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Hyaluronic Acid
Magnesium trisilicate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents