A Phase 4 interventional study of Zinc-l-carnosine and Placebo in Gastroesophageal Reflux Disease, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Phase 4, Interventional, and Treatment
Among 78 studies in Gastroesophageal Reflux with a site in Italy — 12 open to participants now, 14 under way, none of them phase 3. Gastroesophageal Reflux · Italy.
Among the 78 studies in Gastroesophageal Reflux with a site in Italy, this one is the 24th largest by planned enrollment of the 48 interventional ones that give a count, is one of 3 that started in 2018, is one of 5 in phase 4, and was the 43rd registered.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
Browse Gastroesophageal Reflux studies →12 of the 78 studies in Gastroesophageal Reflux with a site in Italy are open now. Recruiting first, the newest first:
IRCCS San Raffaele · Sites in Italy
Ages 18+ · Healthy volunteers
Devintec Sagl · Sites in Italy
Ages 18–75
United Pharmaceuticals · Sites in Italy, Belgium, France and 1 more country
Ages 2 wk–4 mo
Implantica CE Reflux Ltd. · Sites in Italy, Germany, Norway and 1 more country
Ages 18+
Medtronic Cardiovascular · Sites in Italy, Denmark, France and 5 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 132 Gastroesophageal Reflux studies recruiting now, 56 (42%) set no upper age limit and 53 (40%) stop at 75 or younger; 22 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 7 · Phase 3 11 · Phase 4 5
First in 1995; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Median enrollment 80 across the 48 interventional studies, 139 across the 30 observational. Of the 52 that completed or were terminated, 12 (23%) have results posted.
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36 of 78 have an industry lead sponsor. The 10 most frequent:
Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 258 studies on the registry; 115 are open to participants now.
Fondazione IRCCS Policlinico San Matteo di Pavia has 1 study filed under Gastroesophageal Reflux — fewer than ten, so there is no comparison to draw.
4 of the studies in Gastroesophageal Reflux with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04358146United PharmaceuticalsStudy on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR) | 2026-12-03 |
| NCT06984484Devintec SaglPerformance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease | 2027-01 |
| NCT07036627University of BariIntestinal Microbiota After PPI Treatment | 2027-01-01 |
| NCT07790549Liaquat University of Medical & Health SciencesMirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease | 2027-01-29 |
Add all 4 to your calendar (.ics) → With an account.
Among the 78 studies in Gastroesophageal Reflux with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
allergy or intolerance to Hepilor® (it contains parahydroxybenzoate that may cause allergies)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 the investigational product as already mentioned (blindly).
Patients will be asked to take placebo as already mentioned (blindly).
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 16 weeks
Plan to share: Yes — All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: Only on future articles that will be published.
Started Nov 2018 (actual). Primary completion is estimated for Apr 2020, 16 months after the start.
Of 30 phase 4 interventional studies under Gastroesophageal Reflux, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Policlinico San Matteo di Pavia →