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

NCT03467438 | Unknown Phase 4 DMC

• 1 other identifier: GERDILOR17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

heartburn; pyrosis; regurgitation

Outcome Measures

Primary Outcomes (3)

• 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.

  4 weeks

• 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.

  8 weeks

• 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.

  12 weeks

Secondary Outcomes (2)

• 36 item short form health survey

  12 weeks

• Sustained GERD remission

  16 weeks

Study Arms (2)

A

EXPERIMENTAL

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

B

PLACEBO COMPARATOR

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

Interventions

Zinc-l-carnosine DRUG

Patients will be asked to take the investigational product as already mentioned (blindly).

A

Placebo OTHER

Patients will be asked to take placebo as already mentioned (blindly).

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 16928254 BACKGROUND

• 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.

  PMID: 2331952 BACKGROUND

• 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.

  PMID: 9136821 BACKGROUND

• 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.

  PMID: 8189759 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

polaprezinc

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Di Sabatino, MD

CONTACT

00390382502973; a.disabatino@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the First Department of Internal Medicine

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 16, 2018
• Study Start: November 22, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Only on future articles that will be published.

Locations

IT (1)