Clinical Study Evaluating The Role of Vonoprazan Versus Pantoprazole in Patients With Gastroesophageal Reflux Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age17-60
SponsorTanta University
About this trial
This study aims to investigate the possible efficacy of vonoprazan versus Pantoprazole in patients with gastroesophageal reflux disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Vonoprazan 20 mg versus Pantoprazole 40 mg
DrugPatients divided into two arms First Arm administered vonoprazan Second arm administered pantoprazole
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Vonoprazan 20mg (Vonseca)Active comparator 1 intervention
Group B: Pantoprazole 40 mg (Pantoloc)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
change in the measured biomarker
Measured biomarkers are serum gastrin hormone and E-Cadherin level
Time frame
Before and after 2 monthsSecondary outcomes
1
Change in gastroesophageal reflux disease symptoms (The Structured Assessment of Gastrointestinal Symptoms Questionnaire).
Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) is a validated measure of the intensity and impact of 22 upper and lower gastrointestinal symptoms. Responses are given on a 5 point Likert scale from no problem, mild (can be ignored when you do not think about it), moderate (cannot be ignored, but does not influence daily activities), severe (influencing your concentration on daily activities) and very severe (markedly influences your daily activities \&/or requires rest) problem. In addition the SAGIS asks about the presence of selected non gastrointestinal symptoms including headache, chronic fatigue, back pain, sleep disturbances, depression and anxiety. The patient also answers the following questions, "In your own words, what is your most important health concern or problem?" and "In your own words, what is your second most important health concern or problem?
Time frame
Before and after 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov