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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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • Vonoprazan

    Drug

    Vonaprazon is potassium competitive acid blockers

  • Esomeprazole 40mg

    Drug

    esomeprazole is a proton pump inhibitor as it prevents excess of gastric acid secretion in the stomach

Treatment groups

414 Participants
are divided into 3 treatment groups
Group A: To determine whether Vonaprazon 10mg heals grade B esophagitis at 8 weeksOther 1 intervention
Group B: To determine whether Vonaprazon 20mg heals grade B esophagitis at 8 weeksOther 1 intervention
Group C: To determine whether esomeprazole 40mg heals grade B esophagitis at 8 weeksOther 1 intervention

Trial outcomes

Primary outcomes

1

• Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).

healing of ulcers after taking vonaprazon 10mg, 20 mg

Time frame
8 weeks
2

Endoscopic healing of reflux esophagitis at 8 weeks (defined as resolution of LA grade B, C, or D esophagitis).

healing of ulcers after taking esomeprazole 40mg

Time frame
8 weeks

Secondary outcomes

1

• GERD-Q score improvement at 8 weeks (compared to baseline).

symtoms improvement like heartburn, regurgitation which can be calculated with scale 1 (mild symptoms ) to 5 (worse symptoms)

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asian Institute of Gastroenterology, India

Lead sponsor

Source ClinicalTrials.gov
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