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

IRCCS Policlinico S. Matteo

Status and phase: Unknown; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Zinc-l-carnosine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03467438

GERDILOR17

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

A

Experimental group

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).

Treatment:

Drug: Zinc-l-carnosine

B

Placebo Comparator group

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).

Treatment:

Other: Placebo