Gastroesophageal Reflux DiseasePhase 4TOP-GERDNCT06991348
Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole
A Phase 4 study testing Tegoprazan and Pantoprazole in people with Gastroesophageal Reflux Disease, run by Carnot Laboratories at 2 sites in Mexico.
Trial summary
The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and females. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Tegoprazan and Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesMexico
- Study dates
- 30 Jul 2024to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With endoscopic diagnosis of GERD or NERD (endoscopy ≤ 15 days old)
- With positive impedance pHmetry results (pHmetry ≤ 15 days old)
- With recurrent symptoms of heartburn and regurgitation for a previous period ≥ 3 months old
Who cannot join
- With known hypersensitivity to tegoprazan, pantoprazole, or any of the components of each formulation
- Subjects with concomitant administration of atazanavir, nelfinavir or rilpivirine
- Nephropathic and/or hepatopathic subjects (including non-alcoholic hepatitis)
- Subjects with upper gastrointestinal tract bleeding
- Subjects with gastric and/or duodenal ulcer 2 months prior to screening
- Subjects with a history of esophageal or gastric surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico2 sites, 2 recruiting
- Recruiting
Saluz Investigación, S.C.
Boca del Río, Veracruz, 94299
Jose M Remes-Troche, Dr, +52 (229) 921 8869, jose.remes.troche@gmail.com
Jose M Remes-Troche, Dr
- Recruiting
Gastrologen S.A. de C.V.
Mexico City, Mexico City, 01900
Luis R Valdovinos-Garcia, Dr, +52 (55) 6464 4227, drprapul@gmail.com
Luis R Valdovinos-Garcia, Dr
About this study
Official title: Multicenter, Active-controlled, Randomized, Double-blind, Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole: TOP-GERD
The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and females. The main question is What is the proportion of patients with resolution of the main symptoms of gastroesophageal reflux disease at four weeks of treatment with pantoprazole vs tegoprazan.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Tegoprazan, Pantoprazole
- Keywords
- GERD, pantoprazole, tegoprazan, P-CAB, PPI
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Tegoprazan 50 mg daily for 28 days
PantoprazoleDrug
Pantoprazole 40 mg daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Non-erosive GERD - Test product | Experimental | Non-erosive GERD - Tegoprazan Receives: Drug: Tegoprazan |
| Non-erosive GERD - Comparator | Active comparator | Non-erosive GERD - Pantoprazole Receives: Drug: Pantoprazole |
| Erosive GERD - Test product | Experimental | Erosive GERD - Tegoprazan Receives: Drug: Tegoprazan |
| Erosive GERD - Comparator | Active comparator | Erosive GERD - Pantoprazol Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease
Carlsson-Dent Questionnaire. These tool consists of 7 multiple-choice questions, using a cut-off point ≥ 4 to be considered positive, which qualitatively assesses symptoms associated with GERD and triggering factors such as diet, posture and medications used.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start30 Jul 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carnot Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose M Remes-Troche, Dr, Principal investigator, Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Veracruz , México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991348
- Sponsor's protocol ID
- CRN-GA-01-2022
- Acronym
- TOP-GERD
- Status last verified
- Jul 2025
- First submitted
- 20 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only IPD used in the results publication
Publications
Cho YK, Kim JH, Kim HS, Kim TO, Oh JH, Choi SC, Moon JS, Lee SK, Jung SW, Kim SS, Jung HK, Lee SP, Cheon GJ, Park MI, Jung HY, Ko KH, Sung IK, Lee SH, Lee JY, Lee ST, Rhee PL, Kim N, Hong SJ, Kim HJ, Kim GH, Lee KJ, Kim SK, Shin WG, Lee OY. Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis. Aliment Pharmacol Ther. 2023 Jan;57(1):72-80. doi: 10.1111/apt.17255. Epub 2022 Oct 31.
PubMed 36314172Remes-Troche JM, Valdovinos-Garcia LR, Gyawali CP, Vargas-Basurto JL, Reyes-Medina CA, Gonzalez-Hernandez GV, Mendez ARB, Cordova HHB, Thomas-Dupont P, Grube-Pagola P. The TOP-GERD Trial: Comparative Efficacy of Tegoprazan Versus Pantoprazole in the Treatment of Erosive Oesophagitis in a Non-Asian Population. Aliment Pharmacol Ther. 2026 Oct 3. doi: 10.1111/apt.71032. Online ahead of print.
PubMed 42829447
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Active-controlled, Randomized, Double-blind, Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole: TOP-GERD
- ClinicalTrials.gov ID
- NCT06991348
- Acronym / sponsor ID
- TOP-GERD / CRN-GA-01-2022
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, pantoprazole, tegoprazan, P-CAB, PPI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Carnot LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 27 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and females. The main question is What is the proportion of patients with resolution of the main symptoms of gastroesophageal reflux disease at four weeks of treatment with pantoprazole vs tegoprazan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-erosive GERD - Test product | Experimental | Drug: TegoprazanNon-erosive GERD - Tegoprazan |
| Non-erosive GERD - Comparator | Active comparator | Drug: PantoprazoleNon-erosive GERD - Pantoprazole |
| Erosive GERD - Test product | Experimental | Drug: TegoprazanErosive GERD - Tegoprazan |
| Erosive GERD - Comparator | Active comparator | Drug: PantoprazoleErosive GERD - Pantoprazol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With endoscopic diagnosis of GERD or NERD (endoscopy ≤ 15 days old)
- With positive impedance pHmetry results (pHmetry ≤ 15 days old)
- With recurrent symptoms of heartburn and regurgitation for a previous period ≥ 3 months old
Key exclusion criteria (6 listed)
- With known hypersensitivity to tegoprazan, pantoprazole, or any of the components of each formulation
- Subjects with concomitant administration of atazanavir, nelfinavir or rilpivirine
- Nephropathic and/or hepatopathic subjects (including non-alcoholic hepatitis)
- Subjects with upper gastrointestinal tract bleeding
- Subjects with gastric and/or duodenal ulcer 2 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegoprazanTegoprazan 50 mg daily for 28 days | Drug | Erosive GERD - Test product, Non-erosive GERD - Test product |
| PantoprazolePantoprazole 40 mg daily for 28 days | Drug | Erosive GERD - Comparator, Non-erosive GERD - Comparator |
Primary outcome
Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease
Time frame: From enrollment to the end of treatment at 4 weeks
Carlsson-Dent Questionnaire. These tool consists of 7 multiple-choice questions, using a cut-off point ≥ 4 to be considered positive, which qualitatively assesses symptoms associated with GERD and triggering factors such as diet, posture and medications used.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 36314172Cho YK, Kim JH, Kim HS, Kim TO, Oh JH, Choi SC, Moon JS, Lee SK, Jung SW, Kim SS, Jung HK, Lee SP, Cheon GJ, Park MI, Jung HY, Ko KH, Sung IK, Lee SH, Lee JY, Lee ST, Rhee PL, Kim N, Hong SJ, Kim HJ, Kim GH, Lee KJ, Kim SK, Shin WG, Lee OY. Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis. Aliment Pharmacol Ther. 2023 Jan;57(1):72-80. doi: 10.1111/apt.17255. Epub 2022 Oct 31.
- Derived from this study: PubMed 42829447Remes-Troche JM, Valdovinos-Garcia LR, Gyawali CP, Vargas-Basurto JL, Reyes-Medina CA, Gonzalez-Hernandez GV, Mendez ARB, Cordova HHB, Thomas-Dupont P, Grube-Pagola P. The TOP-GERD Trial: Comparative Efficacy of Tegoprazan Versus Pantoprazole in the Treatment of Erosive Oesophagitis in a Non-Asian Population. Aliment Pharmacol Ther. 2026 Oct 3. doi: 10.1111/apt.71032. Online ahead of print.
- Individual participant dataSharing planned: No. Only IPD used in the results publication
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose M Remes-Troche, Dr principal investigator
Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Veracruz , México
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegoprazan and Pantoprazole in people with Gastroesophageal Reflux Disease, run by Carnot Laboratories at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06991348, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.