Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease

NCT06564246 | Recruiting Phase 4

• 1 other identifier: PT(829)
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Vonoprazan; Pantoprazole; Gastroesophageal Reflux Disease (GERD); Gastrin serum level; E-Cadherin level

Outcome Measures

Primary Outcomes (1)

• change in the measured biomarker

  Measured biomarkers are serum gastrin hormone and E-Cadherin level

  Before and after 2 months

Secondary Outcomes (1)

• Change in gastroesophageal reflux disease symptoms (The Structured Assessment of Gastrointestinal Symptoms Questionnaire).

  Before and after 2 months

Study Arms (2)

Vonoprazan 20mg (Vonseca)

ACTIVE COMPARATOR

• Group 1 (control group): 22 patients who will receive Vonoprazan 20mg (Vonseca) and placebo of pantoprazole (pantoloc) daily for 8 weeks

Drug: Vonoprazan 20 mg versus Pantoprazole 40 mg

Pantoprazole 40 mg (Pantoloc)

ACTIVE COMPARATOR

• Group 2: 22 patients who will receive Pantoprazole 40 mg (Pantoloc) and placebo of vonoprazan (vonseca) daily for 8 weeks.

Drug: Vonoprazan 20 mg versus Pantoprazole 40 mg

Interventions

Vonoprazan 20 mg versus Pantoprazole 40 mg DRUG

Patients divided into two arms First Arm administered vonoprazan Second arm administered pantoprazole

Also known as: Vononoprazan (Vonesca) versus pantoprazole (pantoloc)

Pantoprazole 40 mg (Pantoloc); Vonoprazan 20mg (Vonseca)

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 17-60 years.
• Both genders.
• Patients with a score ≥ 8 on the Gastroesophageal Reflux Disease Questionnaire (Gerd Q) are defined as having GERD and will enroll in this study and it will be done at baseline and after 8 weeks.

You may not qualify if:

• Subjects with history of gastrointestinal disease, gastroduodenal surgery, inflammatory bowel disease and Barrett's esophagus.
• Subjects with an earlier or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders (gastric or duodenal ulcer).
• Subjects with history of total/subtotal gastrectomy and esophageal achalasia.
• Subjects with Corona virus disease (COVID19).
• Subjects with major cardiological, respiratory, endocrine metabolic disease and neuro-psychological disease.
• Pregnancy or lactation.
• Subjects with total bilirubin level ≥ 1.2 mg/dl and ALT level \> 100 IU/l.
• Subjects with renal impairment (Crcl less than 30 ml/min).
• Patients receiving atazanavir sulphate, nelfinavir and rilpivirine hydrochloride due to potential drug interactions.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Theodore Billiharz Institute for Researchs

Giza, Egypt

RECRUITING

Related Publications (11)

• Kim YS, Kim TH, Choi CS, Shon YW, Kim SW, Seo GS, Nah YH, Choi MG, Choi SC. Effect of itopride, a new prokinetic, in patients with mild GERD: a pilot study. World J Gastroenterol. 2005 Jul 21;11(27):4210-4. doi: 10.3748/wjg.v11.i27.4210.

  PMID: 16015691 BACKGROUND

• Sakurai K, Suda H, Fujie S, Takeichi T, Okuda A, Murao T, Hasuda K, Hirano M, Ito K, Tsuruta K, Hattori M. Short-Term Symptomatic Relief in Gastroesophageal Reflux Disease: A Comparative Study of Esomeprazole and Vonoprazan. Dig Dis Sci. 2019 Mar;64(3):815-822. doi: 10.1007/s10620-018-5365-0. Epub 2018 Nov 10.

  PMID: 30415407 BACKGROUND

• Altomare A, Guarino MP, Cocca S, Emerenziani S, Cicala M. Gastroesophageal reflux disease: Update on inflammation and symptom perception. World J Gastroenterol. 2013 Oct 21;19(39):6523-8. doi: 10.3748/wjg.v19.i39.6523.

  PMID: 24151376 BACKGROUND

• Armstrong D. Endoscopic evaluation of gastro-esophageal reflux disease. Yale J Biol Med. 1999 Mar-Jun;72(2-3):93-100.

  PMID: 10780570 BACKGROUND

• Hongo M, Kinoshita Y, Miwa H, Ashida K. The demographic characteristics and health-related quality of life in a large cohort of reflux esophagitis patients in Japan with reference to the effect of lansoprazole: the REQUEST study. J Gastroenterol. 2008;43(12):920-7. doi: 10.1007/s00535-008-2257-7. Epub 2008 Dec 24.

  PMID: 19107335 BACKGROUND

• Pace F, Negrini C, Wiklund I, Rossi C, Savarino V; ITALIAN ONE INVESTIGATORS STUDY GROUP. Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2005 Aug 15;22(4):349-56. doi: 10.1111/j.1365-2036.2005.02558.x.

  PMID: 16098002 BACKGROUND

• Laine L, DeVault K, Katz P, Mitev S, Lowe J, Hunt B, Spechler S. Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive Esophagitis: A Randomized Trial. Gastroenterology. 2023 Jan;164(1):61-71. doi: 10.1053/j.gastro.2022.09.041. Epub 2022 Oct 10.

  PMID: 36228734 BACKGROUND

• Shin JM, Kim N. Pharmacokinetics and pharmacodynamics of the proton pump inhibitors. J Neurogastroenterol Motil. 2013 Jan;19(1):25-35. doi: 10.5056/jnm.2013.19.1.25. Epub 2013 Jan 8.

  PMID: 23350044 BACKGROUND

• Abdel-Aziz Y, Metz DC, Howden CW. Review article: potassium-competitive acid blockers for the treatment of acid-related disorders. Aliment Pharmacol Ther. 2021 Apr;53(7):794-809. doi: 10.1111/apt.16295. Epub 2021 Feb 16.

  PMID: 33592125 BACKGROUND

• Laine L, Sharma P, Mulford DJ, Hunt B, Leifke E, Smith N, Howden CW. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022 Jul 1;117(7):1158-1161. doi: 10.14309/ajg.0000000000001735. Epub 2022 Mar 16.

  PMID: 35294415 BACKGROUND

• Koloski NA, Jones M, Hammer J, von Wulffen M, Shah A, Hoelz H, Kutyla M, Burger D, Martin N, Gurusamy SR, Talley NJ, Holtmann G. The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting. Dig Dis Sci. 2017 Aug;62(8):1913-1922. doi: 10.1007/s10620-017-4599-6. Epub 2017 May 27.

  PMID: 28551709 BACKGROUND

Related Links

• Almutairi MB, Alsulaimi SM, Alghamdi RA, et al. Evaluation of GERD Diagnosis, Management, and Outcomes. The Egyptian Journal of Hospital Medicine. 2018 ;72(9):5195-5202.

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Condition Hierarchy (Ancestors)

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

Study Officials

• Aya Hany Abdel Aziz

  Master degree student at faculty of pharmacy - Tanta university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya Hany Abdel Aziz, Bachelor

CONTACT

+201144818823; PG_172956@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student at faculty of pharmacy

Model Details: * Group 1 (control group): 22 patients who will receive Vonoprazan 20mg (Vonseca) and placebo of pantoloc daily for 8 weeks. * Group 2: 22 patients who will receive Pantoprazole 40 mg (Pantoloc) and placebo of vonseca daily for 8 weeks.

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 21, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)