Status:
TERMINATED
Efficacy and Safety of DLBS2411 in the Management of GERD
Lead Sponsor:
Dexa Medica Group
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice daily, given before mor...
Detailed Description
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, twi...
Eligibility Criteria
Inclusion
- Agree to participate in the study under signed informed consent.
- Male or female subjects aged 18-65 years old.
- Subjects with diagnosis of GERD confirmed by endoscopy, with esophagitis grade A-B according to the LA Classification.
- Able to take oral medication.
- Subjects or subjects' legally acceptable representatives are able and willing to record adverse events in diary.
- Subjects or subjects' legally acceptable representatives have the ability to comply with the trial protocol, including instruction for taking trial medication.
Exclusion
- 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
- Subjects with Zollinger Ellison syndrome or peptic ulcer diseases.
- 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.
- Helicobacter pylori positive as confirmed by urea breath test (UBT).
- History of esophageal, gastric or intestinal surgery including vagotomy.
- 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).
- Inadequate liver function defined as ALT or alkaline phosphatase \> 2.5 times upper limit of normal.
- Inadequate renal function defined as estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min.
- Taking any proton pump inhibitors (PPIs) or sucralfate within 14 days prior to screening.
- Requiring regular and chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, aspirin, anticholinergics, cholinergics, spasmolytics, or opiates, misoprostol or prokinetics.
- Hypersensitivity to proton pump inhibitors.
- Subjects with chronic alcoholism (\>40 g alcohol/day) or drug abuse.
- Active heavy smokers (i.e. consuming \>10 cigarettes per day).
- Participation in any other clinical studies within 30 days prior to screening.
Key Trial Info
Start Date :
August 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03367195
Start Date
August 16 2018
End Date
September 9 2020
Last Update
January 7 2021
Active Locations (5)
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1
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Padjajaran Dr. Hasan Sadikin Hospital
Bandung, Indonesia
2
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital
Jakarta, Indonesia, 10430
3
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital
Semarang, Indonesia
4
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital
Surabaya, Indonesia