Efficacy and Safety of DLBS2411 in the Management of GERD

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).

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG

Omeprazole

1 Omeprazole 20 mg capsules twice daily

DRUG

DLBS2411

1 DLBS2411 caplet 250 mg, twice daily

DRUG

Placebo capsule of Omeprazole

1 placebo capsule of omeprazole, twice daily

DRUG

Placebo caplet of DLBS2411

1 placebo caplet of DLBS2411, twice daily

Sponsors & Collaborators

• Dexa Medica Group

  lead INDUSTRY

Principal Investigators

• 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

• 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

• Putut Bayupurnama, SpPD, KGEH · Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital, Yogyakarta, Indonesia

• Hery D. Purnomo, SpPD, KGEH · Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital, Semarang, Indonesia

• 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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-16

Primary Completion

2020-05-04

Completion

2020-09-09

Countries

• Indonesia

Study Locations