Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06955520
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
Sponsor:
Asian Institute of Gastroenterology, India
Organization:
Study Overview
Official Title:
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Peroral Endoscopic Myotomy (POEM) is a well-established treatment for achalasia; however, it is frequently associated with gastroesophageal reflux disease (GERD), with many patients developing LA grade B or higher esophagitis. Proton pump inhibitors (PPIs) like Esomeprazole are the standard treatment, but Vonaprazan, a potassium-competitive acid blocker (P-CAB), offers superior acid suppression and may provide enhanced healing in post-POEM reflux esophagitis.
Primary Objective:
• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg.
Secondary Objectives
* To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks.
* To evaluate the incidence of adverse events in each treatment group.
Primary Objective:
• To compare the healing rates of LA grade B or higher reflux esophagitis at 8 weeks in patients receiving Vonaprazan 20 mg versus Esomeprazole 40 mg.
Secondary Objectives
* To assess improvement in reflux symptoms using the GERD-Q score at 8 weeks.
* To evaluate the incidence of adverse events in each treatment group.
Detailed Description:
Study Type:
• Randomized, Open-Label, Two-Arm, Non-Inferiority Trial
Randomization and Blinding:
* Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg.
* Stratification: Based on LA grade (B vs. C/D) at baseline.
* Blinding: Open-label study, but outcome assessors will be blinded.
Study Timeline:
1. All post-POEM patients receive Esomeprazole 40 mg for 2 months.
2. PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists).
3. At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks.
4. At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed.
Study Arms:
* Arm A: Vonaprazan 20 mg once daily for 8 weeks
* Arm B: Esomeprazole 40 mg once daily for 8 weeks
Study Procedures:
Baseline Assessment (3 Months Post-POEM, Before Randomization)
* Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis.
* GERD-Q Score assessment.
* Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit)
* GERD-Q Score assessment.
End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)
* Upper GI Endoscopy to assess healing of reflux esophagitis.
* GERD-Q Score reassessment.
* Final adverse event reporting.
• Randomized, Open-Label, Two-Arm, Non-Inferiority Trial
Randomization and Blinding:
* Randomization: 1:1 ratio between Vonaprazan 20 mg and Esomeprazole 40 mg.
* Stratification: Based on LA grade (B vs. C/D) at baseline.
* Blinding: Open-label study, but outcome assessors will be blinded.
Study Timeline:
1. All post-POEM patients receive Esomeprazole 40 mg for 2 months.
2. PPI is discontinued for 1 month (to allow reflux esophagitis to develop if persistent GERD exists).
3. At 3 months post-POEM, patients with LA grade B or higher esophagitis (on follow-up endoscopy) are randomized to either Vonaprazan 20 mg or Esomeprazole 40 mg for 8 weeks.
4. At 8 weeks post-randomization (5 months post-POEM), healing of esophagitis is assessed.
Study Arms:
* Arm A: Vonaprazan 20 mg once daily for 8 weeks
* Arm B: Esomeprazole 40 mg once daily for 8 weeks
Study Procedures:
Baseline Assessment (3 Months Post-POEM, Before Randomization)
* Upper GI Endoscopy: Confirmation of LA grade B or higher reflux esophagitis.
* GERD-Q Score assessment.
* Randomization to Vonaprazan 20 mg or Esomeprazole 40 mg. Follow-Up (Week 4 - Interim Visit)
* GERD-Q Score assessment.
End-of-Treatment (Week 8 - Final Visit, 5 Months Post-POEM)
* Upper GI Endoscopy to assess healing of reflux esophagitis.
* GERD-Q Score reassessment.
* Final adverse event reporting.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: