Efficacy and Safety of DLBS2411 in the Management of GERD

Launched by DEXA MEDICA GROUP · Dec 7, 2017

Keywords

ClinConnect Summary

There will be 2 groups of treatment; each group will consist of 129 subjects with the treatment regimens for 8 weeks:

Treatment I : 1 capsule of Omeprazole 20 mg and 1 placebo caplet of DLBS2411, twice daily Treatment II : 1 caplet of DLBS2411 250 mg and 1 placebo capsule of omeprazole, twice daily

Each study medication will be administered twice daily, 30 minutes before morning (the first) and evening (the last) meals.

The eligible subjects will be randomly allocated to receive study medication (Treatment 1 or Treatment 2) for 8 weeks of treatment, in a double blind fashion. They will b...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Agree to participate in the study under signed informed consent.
• • 2. Male or female subjects aged 18-65 years old.
• • 3. Subjects with diagnosis of GERD confirmed by endoscopy, with esophagitis grade A-B according to the LA Classification.
• • 4. Able to take oral medication.
• • 5. Subjects or subjects' legally acceptable representatives are able and willing to record adverse events in diary.
• • 6. Subjects or subjects' legally acceptable representatives have the ability to comply with the trial protocol, including instruction for taking trial medication.
• Exclusion Criteria:
• • 1. For females of childbearing potential: pregnancy and breast-feeding.
• • Patients must accept pregnancy tests during the trial if menstrual cycle is missed
• • Fertile patients must use a reliable and effective contraceptive
• • 2. Subjects with Zollinger Ellison syndrome or peptic ulcer diseases.
• • 3. History or current evidence of Barrett's esophagus, esophageal strictures, odynophagia, pyloric stenosis, esophageal motility disorders (such as achalasia, scleroderma), anatomic esophageal abnormality (such as large hiatal hernia), pill-induced esophagitis.
• • 4. Helicobacter pylori positive as confirmed by urea breath test (UBT).
• • 5. History of esophageal, gastric or intestinal surgery including vagotomy.
• • 6. Presence of comorbid diseases, such as symptomatic coronary artery disease (CAD) or cardiovascular disease, pulmonary disease (including asthma), hemostasis disorder, pancreatitis, malabsorption, or inflammatory bowel disease, and any other chronic diseases (including chronic cough, laryngitis), any serious infection(s), or malignancy(ies).
• • 7. Inadequate liver function defined as ALT or alkaline phosphatase \> 2.5 times upper limit of normal.
• • 8. Inadequate renal function defined as estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min.
• • 9. Taking any proton pump inhibitors (PPIs) or sucralfate within 14 days prior to screening.
• • 10. Requiring regular and chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, aspirin, anticholinergics, cholinergics, spasmolytics, or opiates, misoprostol or prokinetics.
• • 11. Hypersensitivity to proton pump inhibitors.
• • 12. Subjects with chronic alcoholism (\>40 g alcohol/day) or drug abuse.
• • 13. Active heavy smokers (i.e. consuming \>10 cigarettes per day).
• • 14. Participation in any other clinical studies within 30 days prior to screening.