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Trial record 1 of 2 for:    8189759 [PUBMED-IDS]
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Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease (GERDILOR)

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ClinicalTrials.gov Identifier: NCT03467438
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Di Sabatino, IRCCS Policlinico S. Matteo

Brief Summary:

Gastroesophageal reflux disease (GERD), according to the Montreal classification, is defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. GERD, as clinically defined by the presence of heartburn, acid regurgitation, or both, at least once a week, is a global disease, being one of the most common gastroenterological disorders worldwide that affects roughly 10-30% of the general population in the Western world and less than 10% of the Asian populations. GERD complications may be life threatening and range from reflux esophagitis to Barrett's oesophagus and, eventually, adenocarcinoma.

Zinc L-carnosine (brand name in Italy: Hepilor®) is a chelate compound of zinc and L-carnosine, with a long history of more than 20 years of clinical use in Japan that has recently become available in Italy for the treatment of any condition that requires a mucosal protection and mucosal repair within the gastrointestinal tract, thus including GERD. However, clinical data in western countries are limited. The aim of this double-blind, placebo-controlled study is to demonstrate the efficacy of Zinc-l-carnosine in maintaining GERD clinical remission during a 12-week treatment.


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Zinc-l-carnosine Other: Placebo Phase 4

Detailed Description:

The investigators hypothesise that Zinc-l-carnosine is able to maintain GERD remission, thus improving the quality of life of these patients. A comparison with a placebo is necessary, as GERD symptoms may be heavily influenced by the nocebo/placebo effect.

This is a post-marketing, single center, double-blind, and randomized, placebo-controlled, parallel study. Patients with GERD treated with an 8-week cours of proton pump inhibitors will be randomize and receive either Zinc-l-carnosine or placebo for 12-week. GERD symptoms will be assessed with a questionnaire (modified GERD questionnaire by Locke) monthly for 12 weeks and after a 4-week wash-out. Also, quality of life will be assessed at baseline and at 12 weeks with the 36-item short form survey (SF-36).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The manufacturer will provide packages of the investigational medical product/placebo that are indistinguishable. Every package have a code written on it; only the manufacturer knows whether that code refers to the IMD or placebo.
Primary Purpose: Treatment
Official Title: Efficacy of Zinc L-carnosine (Hepilor®) in Maintaining Remission of Gastroesophageal Reflux Disease: a Randomised, Double-blind, Placebo-controlled Study
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: A
Zinc-l-carnosine, liquid oral formulation, 75mg twice daily (20mL, using the measuring cup, twice daily), to be swallowed on an empty stomach (waiting at least one hour from the last meal).
Drug: Zinc-l-carnosine
Patients will be asked to take the investigational product as already mentioned (blindly).

Placebo Comparator: B
Placebo, liquid oral formulation, 75mg twice daily (20mL, using the measuring cup, twice daily), to be swallowed on an empty stomach (waiting at least one hour from the last meal).
Other: Placebo
Patients will be asked to take placebo as already mentioned (blindly).




Primary Outcome Measures :
  1. Gastroesophageal reflux disease (GERD) remission [ Time Frame: 4 weeks ]
    GERD remission will be assessed according to the modified GERD questionnaire by Locke et al. GERD remission is established if any mild symptom does not occur 2 or more days a week, or if any moderate/severe symptom does not occur more than one day a week.

  2. Gastroesophageal reflux disease (GERD) remission [ Time Frame: 8 weeks ]
    GERD remission will be assessed according to the modified GERD questionnaire by Locke et al. GERD remission is established if any mild symptom does not occur 2 or more days a week, or if any moderate/severe symptom does not occur more than one day a week.

  3. Gastroesophageal reflux disease (GERD) remission [ Time Frame: 12 weeks ]
    GERD remission will be assessed according to the modified GERD questionnaire by Locke et al. GERD remission is established if any mild symptom does not occur 2 or more days a week, or if any moderate/severe symptom does not occur more than one day a week.


Secondary Outcome Measures :
  1. 36 item short form health survey [ Time Frame: 12 weeks ]
    Quality of life will be assessed with SF-36 at baseline and after 12 weeks of treatment. The difference between the two groups will be compared at the end of treatment.

  2. Sustained GERD remission [ Time Frame: 16 weeks ]
    GERD remission will be assessed according to the modified GERD questionnaire by Locke et al. after a 4-week wash-out (week 16). GERD remission is established if any mild symptom does not occur 2 or more days a week, or if any moderate/severe symptom does not occur more than one day a week.



Information from the National Library of Medicine

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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:

  • written informed consent to participate
  • be male or female patients ≥ 18 years old, with an established diagnosis of GERD
  • have a diagnosis of GERD that is established clinically in case of typical symptoms (heartburn and acid regurgitation ≥ once weekly) or with 24-hour esophageal impedence monitoring in case of atypical symptoms not responsive to proton pump inhibitors (PPIs) or in case of unclear diagnosis
  • have been treated with an 8-week course of PPI (as per gold-standard treatment of GERD) before entering the study

Exclusion Criteria:

  • any medical condition that requires chronic therapy with PPIs or H2 antagonists; anti-acid agents must be discontinued within the study period
  • oesophageal motility disorders
  • allergy or intolerance to Hepilor® (it contains parahydroxybenzoate that may cause allergies)

    • inconclusive diagnosis of GERD and related symptoms
    • patients with active H. pylori infection (diagnosed with any of the available tests)
    • previous major oesophageal surgery
    • history of any advanced/relevant organ dysfunction, in particular chronic kidney disease, chronic liver disease of any aetiology, hearth failure
    • any concomitant medical condition with a poor prognosis (< 3 months)
    • pregnant females
    • inability to conform to the protocol
    • treatment with any investigational drug within the previous 3 months
    • any subject not able to express/understand the informed consent

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): NCT03467438


Contacts
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Contact: Antonio Di Sabatino, MD 00390382502973 a.disabatino@smatteo.pv.it

Locations
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Italy
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Antonio Di Sabatino, MD    00390382501596    a.disabatino@smatteo.pv.it   
Sponsors and Collaborators
IRCCS Policlinico S. Matteo

Publications:
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Responsible Party: Antonio Di Sabatino, Head of the First Department of Internal Medicine, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT03467438     History of Changes
Other Study ID Numbers: GERDILOR17
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Only on future articles that will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Di Sabatino, IRCCS Policlinico S. Matteo:
heartburn
pyrosis
regurgitation
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
Zinc
Polaprezinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents