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Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease (GERDILOR)

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Zinc-l-carnosine
Placebo
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring heartburn, pyrosis, regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Policlinico San MatteoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Gastroesophageal reflux disease (GERD) remission
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.
Gastroesophageal reflux disease (GERD) remission
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.
Gastroesophageal reflux disease (GERD) remission
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

36 item short form health survey
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.
Sustained GERD remission
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.

Full Information

First Posted
March 5, 2018
Last Updated
February 25, 2019
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT03467438
Brief Title
Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease
Acronym
GERDILOR
Official Title
Efficacy of Zinc L-carnosine (Hepilor®) in Maintaining Remission of Gastroesophageal Reflux Disease: a Randomised, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
heartburn, pyrosis, regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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).
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Zinc-l-carnosine
Intervention Description
Patients will be asked to take the investigational product as already mentioned (blindly).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will be asked to take placebo as already mentioned (blindly).
Primary Outcome Measure Information:
Title
Gastroesophageal reflux disease (GERD) remission
Description
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.
Time Frame
4 weeks
Title
Gastroesophageal reflux disease (GERD) remission
Description
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.
Time Frame
8 weeks
Title
Gastroesophageal reflux disease (GERD) remission
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
36 item short form health survey
Description
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.
Time Frame
12 weeks
Title
Sustained GERD remission
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Di Sabatino, MD
Phone
00390382502973
Email
a.disabatino@smatteo.pv.it
Facility Information:
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Di Sabatino, MD
Phone
00390382501596
Email
a.disabatino@smatteo.pv.it

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
IPD Sharing Time Frame
Only on future articles that will be published.
Citations:
PubMed Identifier
16928254
Citation
Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
Results Reference
background
PubMed Identifier
2331952
Citation
Arakawa T, Satoh H, Nakamura A, Nebiki H, Fukuda T, Sakuma H, Nakamura H, Ishikawa M, Seiki M, Kobayashi K. Effects of zinc L-carnosine on gastric mucosal and cell damage caused by ethanol in rats. Correlation with endogenous prostaglandin E2. Dig Dis Sci. 1990 May;35(5):559-66. doi: 10.1007/BF01540402.
Results Reference
background
PubMed Identifier
9136821
Citation
Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
Results Reference
background
PubMed Identifier
8189759
Citation
Locke GR, Talley NJ, Weaver AL, Zinsmeister AR. A new questionnaire for gastroesophageal reflux disease. Mayo Clin Proc. 1994 Jun;69(6):539-47. doi: 10.1016/s0025-6196(12)62245-9.
Results Reference
background

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Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease

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