Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease

NCT06778395 | Completed Phase 4

• 1 other identifier: ZU-IRB#745/5-Nov-2024
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroenterologists are often hesitated about whether to use the well known PPI in treatment of GERD or the usage of new H/K ATPase inhibitors so its highly needed to test the benefit of each class in Egyptian population to help doctors in decision making

Conditions

Vonoprazan; Proton Pump Inhibitor; Gastroesophageal Reflux Disease

Keywords

Dexlansoprazole; gastroesophageal reflux disease; Vonoprazan

Outcome Measures

Primary Outcomes (1)

• Symptom relief assessed by the GERD-Q score

  8 weeks

Secondary Outcomes (1)

• Frequency scale of the symptoms of gastroesophageal reflux disease questionnaire (FSSG)

  8 weeks

Study Arms (2)

Dexlansoprazole

ACTIVE COMPARATOR

60 mg once daily

Drug: Dexlansoprazole 60 mg

Vonoprazan

ACTIVE COMPARATOR

20 mg twice daily

Drug: Vonoprazan 20 mg bid

Interventions

Dexlansoprazole 60 mg DRUG

once daily for 8 weeks

Dexlansoprazole

Vonoprazan 20 mg bid DRUG

twice daily for 8 weeks

Vonoprazan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of GERD through upper endoscopy

You may not qualify if:

• Patients with a history of previous GERD surgery
• Patients on any proton pump inhibitors (PPIs) or H2 blockers within 4 weeks prior to the study.

Sponsors & Collaborators

• Ayman Magd Eldin Mohammad Sadek: lead
• Zagazig University: collaborator

Study Sites (1)

Zagazig University Hospital

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (8)

• Cheng Y, Liu J, Tan X, Dai Y, Xie C, Li X, Lu Q, Kou F, Jiang H, Li J. Direct Comparison of the Efficacy and Safety of Vonoprazan Versus Proton-Pump Inhibitors for Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2021 Jan;66(1):19-28. doi: 10.1007/s10620-020-06141-5. Epub 2020 Feb 24.

  PMID: 32095968 RESULT

• Zhang M, Xiao Y, Chen M. The role of vonoprazan in patients with erosive esophagitis. Therap Adv Gastroenterol. 2022 Sep 13;15:17562848221122623. doi: 10.1177/17562848221122623. eCollection 2022.

  PMID: 36117573 RESULT

• Manabe N, Joh T, Higuchi K, Iwakiri K, Kamiya T, Haruma K, Nakada K. Clinical significance of gastroesophageal reflux disease with minimal change: a multicenter prospective observational study. Sci Rep. 2022 Sep 3;12(1):15036. doi: 10.1038/s41598-022-19408-w.

  PMID: 36057730 RESULT

• Eusebi LH, Telese A, Cirota GG, Haidry R, Zagari RM, Bazzoli F, Ford AC. Systematic review with meta-analysis: risk factors for Barrett's oesophagus in individuals with gastro-oesophageal reflux symptoms. Aliment Pharmacol Ther. 2021 May;53(9):968-976. doi: 10.1111/apt.16321. Epub 2021 Mar 11.

  PMID: 33705573 RESULT

• Turshudzhyan A, Samuel S, Tawfik A, Tadros M. Rebuilding trust in proton pump inhibitor therapy. World J Gastroenterol. 2022 Jun 28;28(24):2667-2679. doi: 10.3748/wjg.v28.i24.2667.

  PMID: 35979162 RESULT

• Richter JE, Rubenstein JH. Presentation and Epidemiology of Gastroesophageal Reflux Disease. Gastroenterology. 2018 Jan;154(2):267-276. doi: 10.1053/j.gastro.2017.07.045. Epub 2017 Aug 3.

  PMID: 28780072 RESULT

• Jung HK, Tae CH, Song KH, Kang SJ, Park JK, Gong EJ, Shin JE, Lim HC, Lee SK, Jung DH, Choi YJ, Seo SI, Kim JS, Lee JM, Kim BJ, Kang SH, Park CH, Choi SC, Kwon JG, Park KS, Park MI, Lee TH, Kim SY, Cho YS, Lee HH, Jung KW, Kim DH, Moon HS, Miwa H, Chen CL, Gonlachanvit S, Ghoshal UC, Wu JCY, Siah KTH, Hou X, Oshima T, Choi MY, Lee KJ; Korean Society of Neurogastroenterology and Motility. 2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease. J Neurogastroenterol Motil. 2021 Oct 30;27(4):453-481. doi: 10.5056/jnm21077.

  PMID: 34642267 RESULT

• Al-Marhabi A, Hashem A, Zuberi BF, Onyekwere C, Lodhi I, Mounir M, Alkhowaiter S, Al Awadhi S, Naidoo VG, Hamada Y. The views of African and Middle Eastern Gastroenterologists on the management of mild-to-moderate, non-erosive gastro-esophageal reflux disease (GERD). Expert Rev Gastroenterol Hepatol. 2022 Mar;16(3):217-233. doi: 10.1080/17474124.2022.2043744. Epub 2022 Feb 25.

  PMID: 35184616 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; BID protein, human

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ayman Sadek, MD

  Zagazig University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)