VonoprazanPhase 4NCT06778395
Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease
A Phase 4 study testing Dexlansoprazole 60 mg and Vonoprazan 20 mg bid in people with Vonoprazan and Proton Pump Inhibitor, run by Ayman Magd Eldin Mohammad Sadek at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vonoprazan, Proton Pump Inhibitor, Gastroesophageal Reflux Disease
- What is being tested?
- Dexlansoprazole 60 mg and Vonoprazan 20 mg bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of GERD through upper endoscopy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease in Egyptian Patients: A Prospective Comparative Study
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
Read the detailed description
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder that occurs when gastric contents reflux into the esophagus and oral cavity, resulting in troublesome symptoms and/or complications. These include heartburn, a burning sensation in the chest, acid regurgitation, or an ongoing cough. Serious complications include dysphagia and Barrett's esophagus, potentially leading to esophageal adenocarcinoma.
GERD is a common condition, often due to abnormalities in the lower esophageal sphincter, with a pooled global prevalence of 13.3% or more of the population reporting at least weekly symptoms with rates increasing; however, with appreciable geographical variation. As a result, GERD is typically the most frequent gastrointestinal disorder across countries, with consultation rates in ambulatory care ranging from 5.4% to 56% of all consultations. Although GERD cannot be classified as a single disease, it is often used as an umbrella term.
Endoscopy is used to identify GERD, as well as clinical signs including heartburn and acid regurgitation. The two types of GERD are either erosive or non-erosive reflux disease.
The main therapeutic option for GERD is proton pump inhibitors [PPIs], which are superior to other medications in terms of symptom alleviation and mucosal healing. PPIs are known as first-line treatments in individuals with GERD.
Dexlansoprazole, which is the seventh proton pump inhibitor (PPI) to enter the market, is currently one of six PPIs available. It has been used clinically in various formulations as a racemic mixture. The chemical structure of lansoprazole contains an asymmetric sulfinyl group with a chiral center, resulting in two enantiomers, R (+) and S (-). Dexlansoprazole is the R-enantiomer. While the R and S isomers exhibit comparable pharmacological characteristics, research conducted in laboratory settings and living organisms has revealed that the dominant factor behind the inhibitory effects of racemic lansoprazole on the secretion of gastric acid is mainly dexlansoprazole.
Vonoprazan is known as a new family in the suppression of gastric acid which is a potassium-competitive acid blocker [P-CABs]. In comparison to PPIs, P-CABs reversibly inhibit H+ and K+ ATPase, resulting in a great and long-term suppression of acid secretion. As reported in some studies, the rate of healing of reflux esophagitis was superior to that of a PPI [lansoprazole], with a greater effect seen in cases with greater severity.
P-CABs act faster than PPIs and reach their peak in acid inhibition impact post-treatment, whereas PPIs take three to five days. However, few researchers have looked at whether Vonoprazan's faster affects the clinical impact on GERD symptoms of acid regurgitation as weak as heartburn.
- Being tested
- Dexlansoprazole 60 mg, Vonoprazan 20 mg bid
- Keywords
- Dexlansoprazole, gastroesophageal reflux disease, Vonoprazan
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexlansoprazole 60 mgDrug
once daily for 8 weeks
Vonoprazan 20 mg bidDrug
twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dexlansoprazole | Active comparator | 60 mg once daily Receives: Drug: Dexlansoprazole 60 mg |
| Vonoprazan | Active comparator | 20 mg twice daily Receives: Drug: Vonoprazan 20 mg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom relief assessed by the GERD-Q score
Measured: 8 weeks
Secondary outcomes (1)
Frequency scale of the symptoms of gastroesophageal reflux disease questionnaire (FSSG)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Oct 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for VonoprazanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayman Magd Eldin Mohammad Sadek
- Sponsor type
- Other government
- Collaborators
- Zagazig University
- Responsible party
- Sponsor-investigator, Ayman Magd Eldin Mohammad Sadek, Zagazig University
- Investigators
- Ayman Sadek, MD, Study chair, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778395
- Sponsor's protocol ID
- ZU-IRB#745/5-Nov-2024
- Status last verified
- Feb 2025
- First submitted
- 12 Jan 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32095968Zhang M, Xiao Y, Chen M. The role of vonoprazan in patients with erosive esophagitis. Ther Adv Gastroenterol. 2022 Sep 13;15:17562848221122623. doi: 10.1177/17562848221122623. eCollection 2022.
PubMed 36117573Manabe 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.
PubMed 36057730Eusebi 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.
PubMed 33705573Turshudzhyan 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.
PubMed 35979162Richter 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.
PubMed 28780072Jung 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.
PubMed 34642267Al-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.
PubMed 35184616
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease in Egyptian Patients: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06778395
- Acronym / sponsor ID
- ZU-IRB#745/5-Nov-2024
- Keywords
- Dexlansoprazole, gastroesophageal reflux disease, Vonoprazan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ayman Magd Eldin Mohammad SadekOther government
- Collaborators
- Zagazig University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder that occurs when gastric contents reflux into the esophagus and oral cavity, resulting in troublesome symptoms and/or complications. These include heartburn, a burning sensation in the chest, acid regurgitation, or an ongoing cough. Serious complications include dysphagia and Barrett's esophagus, potentially leading to esophageal adenocarcinoma.
GERD is a common condition, often due to abnormalities in the lower esophageal sphincter, with a pooled global prevalence of 13.3% or more of the population reporting at least weekly symptoms with rates increasing; however, with appreciable geographical variation. As a result, GERD is typically the most frequent gastrointestinal disorder across countries, with consultation rates in ambulatory care ranging from 5.4% to 56% of all consultations. Although GERD cannot be classified as a single disease, it is often used as an umbrella term.
Endoscopy is used to identify GERD, as well as clinical signs including heartburn and acid regurgitation. The two types of GERD are either erosive or non-erosive reflux disease.
The main therapeutic option for GERD is proton pump inhibitors [PPIs], which are superior to other medications in terms of symptom alleviation and mucosal healing. PPIs are known as first-line treatments in individuals with GERD.
Dexlansoprazole, which is the seventh proton pump inhibitor (PPI) to enter the market, is currently one of six PPIs available. It has been used clinically in various formulations as a racemic mixture. The chemical structure of lansoprazole contains an asymmetric sulfinyl group with a chiral center, resulting in two enantiomers, R (+) and S (-). Dexlansoprazole is the R-enantiomer. While the R and S isomers exhibit comparable pharmacological characteristics, research conducted in laboratory settings and living organisms has revealed that the dominant factor behind the inhibitory effects of racemic lansoprazole on the secretion of gastric acid is mainly dexlansoprazole.
Vonoprazan is known as a new family in the suppression of gastric acid which is a potassium-competitive acid blocker [P-CABs]. In comparison to PPIs, P-CABs reversibly inhibit H+ and K+ ATPase, resulting in a great and long-term suppression of acid secretion. As reported in some studies, the rate of healing of reflux esophagitis was superior to that of a PPI [lansoprazole], with a greater effect seen in cases with greater severity.
P-CABs act faster than PPIs and reach their peak in acid inhibition impact post-treatment, whereas PPIs take three to five days. However, few researchers have looked at whether Vonoprazan's faster affects the clinical impact on GERD symptoms of acid regurgitation as weak as heartburn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexlansoprazole | Active comparator | Drug: Dexlansoprazole 60 mg60 mg once daily |
| Vonoprazan | Active comparator | Drug: Vonoprazan 20 mg bid20 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of GERD through upper endoscopy
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexlansoprazole 60 mgonce daily for 8 weeks | Drug | Dexlansoprazole |
| Vonoprazan 20 mg bidtwice daily for 8 weeks | Drug | Vonoprazan |
Primary outcome
Symptom relief assessed by the GERD-Q score
Time frame: 8 weeks
1 secondary outcome
Frequency scale of the symptoms of gastroesophageal reflux disease questionnaire (FSSG)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Results publication: PubMed 32095968Cheng 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.
- Results publication: PubMed 36117573Zhang M, Xiao Y, Chen M. The role of vonoprazan in patients with erosive esophagitis. Ther Adv Gastroenterol. 2022 Sep 13;15:17562848221122623. doi: 10.1177/17562848221122623. eCollection 2022.
- Results publication: PubMed 36057730Manabe 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.
- Results publication: PubMed 33705573Eusebi 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.
- Results publication: PubMed 35979162Turshudzhyan 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.
- Results publication: PubMed 28780072Richter 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.
- Results publication: PubMed 34642267Jung 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.
- Results publication: PubMed 35184616Al-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.
- Individual participant dataSharing planned: No
Related trials for Vonoprazan
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RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
Not yet recruitingPhase 4
Efficacy Comparison of 10-Day High-Dose Versus 14-Day Standard-Dose Vonoprazan Plus Amoxicillin in Helicobacter Pylori Eradication: A Multicenter Non-Inferiority Randomized Controlled Trial
Helicobacter Infection, Vonoprazan
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Sadek, MD study chair
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexlansoprazole 60 mg and Vonoprazan 20 mg bid in people with Vonoprazan and Proton Pump Inhibitor, run by Ayman Magd Eldin Mohammad Sadek at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom relief assessed by the GERD-Q score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778395, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.