Erosive EsophagitisPhase 4INVESTNCT06720610
Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis
A Phase 4 study testing Vonoprazan 20 mg and Esomeprazole in people with Erosive Esophagitis, run by Universitas Indonesia at 5 sites in Indonesia.
Trial summary
The goal of this clinical trial is to compare drug vonoprazan vs esomeprazole effectiveness to relieve early symptoms in Erosive Esophagitis Patients. It will also learn about the safety of both modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- Vonoprazan 20 mg and Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 5 sitesIndonesia
- Study dates
- 9 Dec 2024to 27 Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients aged >18 years with a GERD-Q score of 8.
- Diagnosed with erosive esophagitis by endoscopy. (Los Angeles Classification A-D)
- Patients are willing to undergo a series of therapeutic management.
Who cannot join
- Patients with a history of allergy to PCAB or PPI groups.
- Patients with gastric and/or duodenal ulcers.
- Patients with Helicobacter pylori infection.
- Patients with a history of significant systemic disease disorders affecting the esophagus and stomach.
- Patients with a history of malignant disease related to the esophagus and/or stomach.
- Patients with a history of esophageal and/or gastric surgery.
- Pregnant patients
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Indonesia5 sites
Hermina Bekasi Hospital
Bekasi, West Java, 17141
Nikko Darnindro, MD, +628129734458, nikkodarnindro@gmail.com
Hermina Depok Hospital
Depok, West Java, 16436
Aru Ariadno, MD, +6281384473476, roeariadno@gmail.com
Hermina Jatinegara Hospital
East Jakarta, DKI Jakarta, 13320
Arlyando Saragih, MD, +628128225640, arlyando2020@gmail.com
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Ryan Herardi, MD, +6281381166910, dr.ryanherardi@gmail.com
Hermina Kemayoran Hospital
Jakarta Pusat, DKI Jakarta, 10620
Andry Kurniawan, MD, +628126729703, andreedoc85@gmail.com
About this study
Official title: Comparison of the Effectiveness of Vonoprazan and Esomeprazole in Improving Initial Symptoms in Patients with Erosive Esophagitis: a Double-Blind Randomized Trial
The goal of this clinical trial is to compare drug vonoprazan vs esomeprazole effectiveness to relieve early symptoms in Erosive Esophagitis Patients. It will also learn about the safety of both modalities. The main questions it aims to answer are:
How does the effectiveness of Vonoprazan compare with Esomeprazole in improving early symptoms of erosive esophagitis patients in the Indonesian population?
Read more
Researchers will compare drug vonoprazan to a esomeprazole with a look-alike packaging to see their effect to reduce early symptoms of erosive esophagitis.
Participants will:
- Take drug vonoprazan 20mg or esomeprazole 40mg one time every day for 2 weeks
- Visit the clinic once every weeks for followup (Gastro Esophageal Reflux Disease-Quetionnaire measurement)
- Keep a diary of their adverse effect occurence and every variable data based on Gastro Esophageal Reflux Disease-Questionnaire.
Read the detailed description
Based on the calculation using the formula for comparing two population proportions, the minimum estimated sample size is 97 samples for each group. Considering a potential 10% drop-out rate, the estimated sample size increases to 108 samples per group. Therefore, the total minimum sample required for this study is 216 samples for both groups.
All the patients will screened using the Gastro Esophageal Reflux Disease-Quetionnaire (6 questions, 4 answer options, covering the last 7 days) and collected through RedCap. After that all eligible patients will undergo endoscopic examination that performed by gastroenterology specialists or trained internists.
Included patients who consume any Proton Pump Inhibiotr or Potassium-competitive acid blockers within 2 weeks prior to this study will undergo wash-out period for 2 weeks. Patients are monitored weekly during the wash-out period. Medication reminders are sent via instant messaging at least twice per week. Adverse Event will be monitored by research assistants in coordination with the patient's primary physician.
All the data will analyzed blindly with Chi-square or Fisher's exact test for categorical data and logistic regression for confounding factors. At the end of the study, the pharmacy team will reveal the group allocation.
- Conditions
- Erosive Esophagitis
- Being tested
- Vonoprazan 20 mg, Esomeprazole
- Keywords
- erosive esophagitis, vonoprazan, esomeprazole, gerd-q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan 20 mgDrug
Also called vocinti
Vonoprazan PO, 20mg, once a day, 14 days.
EsomeprazoleDrug
Also called Esomeprazole generic
Esomeprazole PO, 40mg, once a day, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan | Experimental | Each randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively Receives: Drug: Vonoprazan 20 mg |
| Esomeprazole | Active comparator | Each randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Symptoms Resolution of Erosive Esophagitis
Participants achieved a,
- complete resolution if they scored a GERD-Q questionnaire of 0 from scale 0-18. - sufficient relief if they scored GERD-Q of 1 or 0 (No. 1,2,5,6)
- persistent response if they score GERD-Q of 2 or more in any single question.
Measured: 14 days (two weeks)
Secondary outcomes (1)
Number of Participants with Adverse Event
Yes: nasopharyngitis, diarrhea, acute upper respiratory infection, lower back pain, constipation No: none of any
Measured: 14 days (two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start9 Dec 2024 (estimated)
- Primary completion25 Apr 2025 (estimated)
- Study completion27 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Fahrial Syam, Universitas Indonesia
- Investigators
- Ari F Syam, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720610
- Sponsor's protocol ID
- INVEST01
- Other IDs
- 24-08-1382
- Acronym
- INVEST
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Vonoprazan and Esomeprazole in Improving Initial Symptoms in Patients with Erosive Esophagitis: a Double-Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT06720610
- Acronym / sponsor ID
- INVEST / INVEST01
- Conditions
- Erosive Esophagitis
- Keywords
- erosive esophagitis, vonoprazan, esomeprazole, gerd-q
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 27 Jun 2025 (estimated)
- First posted
- 6 Dec 2024 (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.
The goal of this clinical trial is to compare drug vonoprazan vs esomeprazole effectiveness to relieve early symptoms in Erosive Esophagitis Patients. It will also learn about the safety of both modalities. The main questions it aims to answer are:
How does the effectiveness of Vonoprazan compare with Esomeprazole in improving early symptoms of erosive esophagitis patients in the Indonesian population?
Researchers will compare drug vonoprazan to a esomeprazole with a look-alike packaging to see their effect to reduce early symptoms of erosive esophagitis.
Participants will:
- Take drug vonoprazan 20mg or esomeprazole 40mg one time every day for 2 weeks
- Visit the clinic once every weeks for followup (Gastro Esophageal Reflux Disease-Quetionnaire measurement)
- Keep a diary of their adverse effect occurence and every variable data based on Gastro Esophageal Reflux Disease-Questionnaire.
Detailed description
Based on the calculation using the formula for comparing two population proportions, the minimum estimated sample size is 97 samples for each group. Considering a potential 10% drop-out rate, the estimated sample size increases to 108 samples per group. Therefore, the total minimum sample required for this study is 216 samples for both groups.
All the patients will screened using the Gastro Esophageal Reflux Disease-Quetionnaire (6 questions, 4 answer options, covering the last 7 days) and collected through RedCap. After that all eligible patients will undergo endoscopic examination that performed by gastroenterology specialists or trained internists.
Included patients who consume any Proton Pump Inhibiotr or Potassium-competitive acid blockers within 2 weeks prior to this study will undergo wash-out period for 2 weeks. Patients are monitored weekly during the wash-out period. Medication reminders are sent via instant messaging at least twice per week. Adverse Event will be monitored by research assistants in coordination with the patient's primary physician.
All the data will analyzed blindly with Chi-square or Fisher's exact test for categorical data and logistic regression for confounding factors. At the end of the study, the pharmacy team will reveal the group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan | Experimental | Drug: Vonoprazan 20 mgEach randomized patients will consume 20mg of vonoprazan once a day for 14 days consecutively |
| Esomeprazole | Active comparator | Drug: EsomeprazoleEach randomized patients will consume 40mg of esomeprazole once a day for 14 days consecutively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged >18 years with a GERD-Q score of 8.
- Diagnosed with erosive esophagitis by endoscopy. (Los Angeles Classification A-D)
- Patients are willing to undergo a series of therapeutic management.
Key exclusion criteria (7 listed)
- Patients with a history of allergy to PCAB or PPI groups.
- Patients with gastric and/or duodenal ulcers.
- Patients with Helicobacter pylori infection.
- Patients with a history of significant systemic disease disorders affecting the esophagus and stomach.
- Patients with a history of malignant disease related to the esophagus and/or stomach.
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 |
|---|---|---|
| Vonoprazan 20 mgAlso: vocintiVonoprazan PO, 20mg, once a day, 14 days. | Drug | Vonoprazan |
| EsomeprazoleAlso: Esomeprazole genericEsomeprazole PO, 40mg, once a day, 14 days | Drug | Esomeprazole |
Primary outcome
Number of Participants with Symptoms Resolution of Erosive Esophagitis
Time frame: 14 days (two weeks)
Participants achieved a, * complete resolution if they scored a GERD-Q questionnaire of 0 from scale 0-18. - sufficient relief if they scored GERD-Q of 1 or 0 (No. 1,2,5,6) * persistent response if they score GERD-Q of 2 or more in any single question.
1 secondary outcome
Number of Participants with Adverse Event
Time frame: 14 days (two weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Erosive Esophagitis
Not yet recruitingPhase 4
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A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
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Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
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Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Gut-Brain Disorders, GERD Without Erosive Esophagitis
Not yet recruitingPhase 3
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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.
Ari F Syam, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan 20 mg and Esomeprazole in people with Erosive Esophagitis, run by Universitas Indonesia at 5 sites in Indonesia.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ari F Syam, MD (+62818706199, ari_syam@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Symptoms Resolution of Erosive Esophagitis (time frame: 14 days (two weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2024.