Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tegoprazan, Pantoprazole.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Tegoprazan
Tegoprazan 50 mg daily for 28 days - Drug Pantoprazole
Pantoprazole 40 mg daily for 28 days
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Mexico · 2 centers
- Gastrologen S.A. de C.V. — Mexico City
- Saluz Investigación, S.C. — Boca del Río
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 PMID 36314172
Identifiers
NCT: NCT06991348 · CRN-GA-01-2022