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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2021 |
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Main ID: |
NCT03367195 |
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Date of registration:
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27/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of DLBS2411 in the Management of GERD
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Scientific title:
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Efficacy and Safety of DLBS2411 Compared to Omeprazole in the Management of Gastroesophageal Reflux Disease (GERD) |
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Date of first enrolment:
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August 16, 2018 |
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Target sample size:
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32 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03367195 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Dolvy Girawan, M. Kes., SpPD, KGEH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Padjajaran Dr. Hasan Sadikin Hospital, Bandung, Indonesia |
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Name:
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Hery D. Purnomo, SpPD, KGEH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital, Semarang, Indonesia |
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Name:
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Iswan A. Nusi, Prof. KGEH, FINASIM, FACG |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital, Surabaya, Indonesia |
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Name:
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Putut Bayupurnama, SpPD, KGEH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital, Yogyakarta, Indonesia |
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Name:
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Dadang Makmun, SpPD, KGEH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta Indonesia |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastroesophageal Reflux Disease (GERD)
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Intervention(s)
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Drug: Omeprazole
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Drug: Placebo capsule of Omeprazole
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Drug: Placebo caplet of DLBS2411
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Drug: DLBS2411
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Primary Outcome(s)
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Healing rate by endoscopy
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Renal function
[Time Frame: 4 and 8 weeks]
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Liver function
[Time Frame: 4 and 8 weeks]
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Vital sign
[Time Frame: 4 and 8 weeks]
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Adverse event
[Time Frame: 4 and 8 weeks]
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Regurgitation response rate
[Time Frame: 4 and 8 weeks]
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Changes in GERD Questionnaire (GERDQ) sum scores
[Time Frame: 4 and 8 weeks]
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Electrocardiography (ECG)
[Time Frame: 8 weeks]
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Heartburn response rate
[Time Frame: 4 and 8 weeks]
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Composite heartburn and regurgitation response rate
[Time Frame: 4 and 8 weeks]
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Overall response rate
[Time Frame: 4 and 8 weeks]
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Secondary ID(s)
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DLBS2411-0213
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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