A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

ConditionGERD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAsian Institute of Gastroenterology, India

About this trial

Primary Objective

• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks among patients treated with Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg once daily.

Secondary Objectives

* To assess the improvement in reflux symptoms using the GERD-Q score at 8 weeks. * To evaluate the incidence of adverse events across treatment groups.

Eligibility criteria

Qualifiers

Adults ≥18 years of age.

Endoscopically confirmed LA grade B, C, or D reflux esophagitis.

GERD symptoms (heartburn, regurgitation) for at least 4 weeks prior to enrollment.

Willing to provide informed consent and comply with study procedures.

Disqualifiers

Previous or ongoing treatment with Vonaprazan or Esomeprazole in the last 4 weeks.

Prior esophageal surgery or radiation therapy.

Barrett's esophagus, esophageal stricture, or malignancy.

Pregnant or breastfeeding women.

Trial design

Treatments tested in this trial

  • Vonoprazan
  • Esomeprazole 40mg

Treatment groups

414 Participants
are divided into 3 treatment groups