ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of DLBS2411 in the Management of GERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03367195
Recruitment Status : Active, not recruiting
First Posted : December 8, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group

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 morning and evening meals, for an 8-week course of therapy. Subjects should avoid taking meals 2-3 hours before bedtime.

The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation.

Recent study of DLBS2411 which was conducted in healthy volunteers, demonstrated the effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is hypothesized to benefit patients with gastric acid disorders such as in gastroesophageal reflux disease (GERD).


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Drug: Omeprazole Drug: DLBS2411 Drug: Placebo capsule of Omeprazole Drug: Placebo caplet of DLBS2411 Phase 3

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, 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 be asked to come to the clinic every 4-week interval throughout the study period. Treatment Group 1 will receive Omeprazole twice daily and Placebo DLBS2411 twice daily. While Treatment Group 2 will receive DLBS2411 twice daily and Placebo Omeprazole twice daily.

Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over the 8-week course of therapy. Throughout the 8-week therapy, subjects should record the frequency (presence and absence) of each of GERD symptoms (heartburn, regurgitation, epigastric pain, nausea) daily in the provided Patient's Diary. The severity of each symptom experienced should also be self-evaluated and recorded.

The safety profile of study medication other than vital signs and adverse event will be measured at baseline and end of study.

Along the study, subjects should avoid taking meals 2-3 hours before bedtime. All subjects will be under direct supervision of a medical doctor during the study period.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of DLBS2411 Compared to Omeprazole in the Management of Gastroesophageal Reflux Disease (GERD)
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Treatment 1
1 Omeprazole capsule 20 mg and 1 placebo caplet of DLBS2411, twice daily
Drug: Omeprazole
1 Omeprazole 20 mg capsules twice daily

Drug: Placebo caplet of DLBS2411
1 placebo caplet of DLBS2411, twice daily
Other Name: Placebo caplet of Redacid

Experimental: Treatment II
1 DLBS2411 caplet 250 mg and 1 placebo capsule of Omeprazole, twice daily
Drug: DLBS2411
1 DLBS2411 caplet 250 mg, twice daily
Other Name: Redacid

Drug: Placebo capsule of Omeprazole
1 placebo capsule of omeprazole, twice daily




Primary Outcome Measures :
  1. Healing rate by endoscopy [ Time Frame: 8 weeks ]
    Healing rate is defined as proportion of subjects with either complete or achieving lower endoscopic grade of esophagitis (according to the Los Angeles (LA) classification) at Week 8 (end of study).


Secondary Outcome Measures :
  1. Changes in GERD Questionnaire (GERDQ) sum scores [ Time Frame: 4 and 8 weeks ]
    Changes in GERDQ sum scores from baseline to Week 4 and Week 8 of treatment.

  2. Composite heartburn and regurgitation response rate [ Time Frame: 4 and 8 weeks ]
    Composite heartburn and regurgitation response rate: defined as proportion of subjects with neither heartburn nor acid regurgitation during the last 7 days (complete resolution of heartburn and acid regurgitation) by Week 4 and Week 8.

  3. Heartburn response rate [ Time Frame: 4 and 8 weeks ]
    Heartburn response rate: defined as proportion of subjects with no heartburn during the last 7 days (complete resolution of heartburn) by Week 4 and Week 8 (end of study).

  4. Regurgitation response rate [ Time Frame: 4 and 8 weeks ]
    Regurgitation response rate: defined as proportion of subjects with no regurgitation during the last 7 days (complete resolution of regurgitation) by Week 4 and Week 8 (end of study).

  5. Overall response rate [ Time Frame: 4 and 8 weeks ]

    Overall response rate: defined as proportion of subjects with controlled GERD symptoms by Week 4 and 8 of treatment, defined as proportion categorized as:

    • complete relief (no GERD symptoms during the last 7-day);
    • partial relief (a decrease in frequency but not complete relief of GERD symptoms during the last 7-day); and
    • no response (increase or no change in frequency of GERD symptoms).

  6. Vital sign [ Time Frame: 4 and 8 weeks ]
    Vital sign (blood pressure) from baseline to every follow-up visit including end of study

  7. Electrocardiography (ECG) [ Time Frame: 8 weeks ]
    Electrocardiography (ECG) at baseline and at the end of study

  8. Liver function [ Time Frame: 4 and 8 weeks ]
    Liver function (serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin)from baseline to every follow-up visit including end of study

  9. Renal function [ Time Frame: 4 and 8 weeks ]
    Renal function (serum creatinine and blood urea nitrogen (BUN) level) from baseline to every follow-up visit including end of study

  10. Adverse event [ Time Frame: 4 and 8 weeks ]
    Adverse event, will be observed throughout the study conduct



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367195


Locations
Indonesia
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Padjajaran Dr. Hasan Sadikin Hospital
Bandung, Indonesia
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital
Jakarta, Indonesia, 10430
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital
Semarang, Indonesia
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital
Surabaya, Indonesia
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital
Yogyakarta, Indonesia
Sponsors and Collaborators
Dexa Medica Group
Investigators
Principal Investigator: Dadang Makmun, SpPD, KGEH Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta Indonesia
Principal Investigator: Iswan A. Nusi, Prof. KGEH, FINASIM, FACG Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital, Surabaya, Indonesia
Principal Investigator: Putut Bayupurnama, SpPD, KGEH Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital, Yogyakarta, Indonesia
Principal Investigator: Hery D. Purnomo, SpPD, KGEH Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital, Semarang, Indonesia
Principal Investigator: Dolvy Girawan, M. Kes., SpPD, KGEH Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Padjajaran Dr. Hasan Sadikin Hospital, Bandung, Indonesia

Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT03367195     History of Changes
Other Study ID Numbers: DLBS2411-0213
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dexa Medica Group:
GERD
DLBS2411
omeprazole

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action