GERD Clinical Trial
Official title:
Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity
The purpose of this study is to determine the efficacy, safety, and tolerability of
omeprazole in combination with domperidone in GERD treatment for subsequent efficient
pharmacotherapy of GERD.
Objectives of the trial To assess the efficacy of omeprazole in combination with domperidone
regarding change of incidence and severity of clinical symptoms of GERD during 8 weeks of
treatment To compare the efficacy of omeprazole in combination with domperidone regarding
change of incidence and severity of clinical symptoms of GERD during 8 weeks of treatment To
assess the efficacy of omeprazole in combination with domperidone regarding change of
incidence and severity of endoscopic symptoms of GERD during 8 weeks of treatment To compare
the efficacy of omeprazole in combination with domperidone regarding change of incidence and
severity of endoscopic symptoms of GERD during 8 weeks of treatment To determine the
efficiency and advantages of one GERD therapy considering efficacy, safety, and individual
variance of patients' reactions
Study design . Primary and secondary endpoints
Primary endpoint:
• reduced incidence and severity of heartburn after 8 weeks of treatment with Omez-DSR
preparation in comparison with OMEZ preparation.
Secondary endpoints:
- reduced severity of heartburn estimated against visual analog scale after 8 weeks of
treatment;
- incidence of events of heartburn after 4 and 8 weeks of treatment;
- proportion of patients with completely jugulated heartburn at the 4th and 8th weeks of
treatment;
- number of days without heartburn after 4 weeks of treatment;
- proportion of patients with resolved esophagitis after 8 weeks of treatment in subjects
with esophagitis at the time of enrollment.
Safety endpoints:
- incidence of adverse events in the group of patients who received at least one dose of
the medicinal product after randomization;
- incidence of serious adverse events;
- incidence of severe adverse events;
- incidence of adverse events definitely caused by administration of the tested medicinal
product.
Description of the trial planned By its design the trial will be a randomized open
comparative parallel study.
Study flow chart:
Screening=>Randomization=>Group 1(Omez-DSR),Group 2(Omez) =>Treatment=>Monitoring
13.3. Phases of the trial:
1. Screening - preliminary selection of subjects according to clinical criteria; signing
of informed consent; prescription and conduction of screening procedures; decision on
inclusion/exclusion of subject from the trial on the grounds of the results of
screening procedures according to inclusion/exclusion criteria.
2. Randomization - random distribution of subjects included into the trial into two
groups: group 1 - treatment with tested Omez-DSR preparation, group 2 - treatment with
the comparator Omez.
3. Treatment - patients receive either Omez-DSR preparation or Omez preparation in the
prescribed regimen according to the randomization number. Treatment shall be
ambulatory; patients shall visit research center through specified periods.
4. After the end of treatment patients shall return to their usual lifestyle, but they are
monitored to assess the efficacy of the therapy conducted and to record adverse events.
Description of measures allowing reducing the bias factor Randomization Randomization at
phase 2 shall be performed using the WinPepi statistical program, option Masking Partial
masking shall be used. Assessment of endoscopic examination at week 8 of treatment shall be
blinded; the specialist conducting endoscopy shall not know which therapy was used.
Statistical analysis shall be performed after coding of subjects; and during analysis it
shall not be known which of the groups is receiving Omez-DSR, and which one - Omez.
Description of treatment Medical preparations authorized in the Republic of Belarus shall be
used in the trial: Omez-DSR and Omez.
Dosage Dosage shall be performed in accordance with label recommendations of Omez-DSR and
Omez preparations. Dose of Omez shall be 2 capsules/day (40 mg of omeprazole). Dose of
Omez-DSR shall be 2 capsules/day (40 mg of omeprazole and 60 mg of domperidone).
Regimen Medicinal preparations shall be prescribed after randomization. Group 1 or OM-DP:
the subjects from this group shall be supplied the preparation enough for 8 weeks of
treatment. Group 2 or OM: the subjects shall be supplied the preparation enough for 8 weeks.
Features of the phases of the trial
Signing of informed consent:Screening, Assessment of inclusion/exclusion
criteria:Screening,Randomization Complaints Screening,Randomization,Week 8/End of
treatment,Monitoring After 28 days
Past and present history: Screening,Randomization Drug history: Screening,Week 8/End of
treatment, Monitoring After 28 days Physical examination: Screening,Randomization,Week 8/End
of treatment, Monitoring After 28 days Height, weight measurement: Screening,Week 8/End of
treatment, Monitoring After 28 days Survey against the GERD-Q scale (values of 7 scores):
Screening,Week 8/End of treatment Distribution of diaries:Randomization
Esophagogastroduodenoscopy: Screening,Week 8/End of treatment Pregnancy test: Screening
Distribution of preparation:Randomization Recording of adverse events:Week 8/End of
treatment, Monitoring After 28 days Compliance assessment:Week 8/End of treatment
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06084572 -
Prospective Evaluation of pH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
|
||
| Completed |
NCT03568825 -
Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose
|
N/A | |
| Recruiting |
NCT04703374 -
A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04120025 -
Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients
|
N/A | |
| Withdrawn |
NCT04771247 -
Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy
|
N/A | |
| Completed |
NCT02575287 -
Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes
|
N/A | |
| Completed |
NCT01710800 -
Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy
|
N/A | |
| Completed |
NCT00287339 -
The Utility of Nexium in Chronic Cough and Reflux Disease
|
Phase 4 | |
| Completed |
NCT00287391 -
Sleep Disorders and Gastroesophageal Reflux Disease (GERD)
|
Phase 4 | |
| Completed |
NCT00629564 -
An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
|
Phase 4 | |
| Completed |
NCT04243668 -
ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
|
N/A | |
| Completed |
NCT03558477 -
PK/PD Clinical Trial of YYD601 in Healthy Adult Male
|
Phase 1 | |
| Recruiting |
NCT05042063 -
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
|
||
| Completed |
NCT05069493 -
Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
|
||
| Terminated |
NCT04626232 -
Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients
|
N/A | |
| Completed |
NCT03238534 -
Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS
|
Phase 4 | |
| Recruiting |
NCT05974722 -
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
|
N/A | |
| Recruiting |
NCT05781347 -
Stretta Versus Conservative Treatment in Obese and Non-obese
|
N/A | |
| Completed |
NCT06141577 -
A Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of UI059 and UIC202201 in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT05108038 -
A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects
|
Phase 1 |