Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis.
Yu Kyung Cho, Jae Hak Kim, Hyun-Soo Kim...
https://pubmed.ncbi.nlm.nih.gov/36314172Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06991348
Multicenter, Active-controlled, Randomized, Double-blind Clinical Trial Comparing Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease with Tegoprazan or Pantoprazole
Led by Carnot Laboratories · Updated on 2025-07-23
128
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two drugs, tegoprazan and pantoprazole, to see which one better resolves symptoms in adult patients diagnosed with erosive and non-erosive gastroesophageal reflux disease (GERD). The study aims to determine the proportion of patients whose main GERD symptoms improve after four weeks of treatment. This phase 4 clinical trial is sponsored by Carnot Laboratories and uses a randomized, double-blind design to ensure unbiased results. Participants are assigned to one of four groups based on their GERD type: non-erosive or erosive. Each group receives either tegoprazan 50 mg or pantoprazole 40 mg, both taken daily for 28 days. This setup allows the study to compare the effectiveness of these two acid-suppressing medications in managing GERD symptoms. During the trial, researchers will monitor symptom resolution from enrollment through the end of the four-week treatment. Participants undergo diagnostic tests such as endoscopy and impedance pHmetry before joining to confirm GERD. The study tracks symptom improvements and safety throughout the treatment period, with the main outcome being the proportion of subjects who experience symptom resolution after four weeks.
CONDITIONS
Brief Title
Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of GERD or non-erosive reflux disease confirmed by endoscopy within 15 days
- Positive impedance pHmetry results within 15 days
- Recurrent heartburn and regurgitation symptoms for at least 3 months
You will not qualify if you...
- Known allergy to tegoprazan, pantoprazole, or their ingredients
- Taking atazanavir, nelfinavir, or rilpivirine medications
- Kidney or liver disease including non-alcoholic hepatitis
- Upper gastrointestinal tract bleeding
- Gastric or duodenal ulcer within 2 months before screening
- History of esophageal or gastric surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 28 days
Participants receive daily administration of either Tegoprazan or Pantoprazole to manage symptoms of gastroesophageal reflux disease.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 2 locations
1
Gastrologen S.A. de C.V.
Mexico City, Mexico City, Mexico, 01900
Actively Recruiting
2
Saluz Investigación, S.C.
Boca del Río, Veracruz, Mexico, 94299
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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