Efficacy and Safety of DLBS2411 in the Management of GERD

NCT03367195 | Terminated Phase 3

• 1 other identifier: DLBS2411-0213
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

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).

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERD; DLBS2411; omeprazole

Outcome Measures

Primary Outcomes (1)

• Healing rate by endoscopy

  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).

  8 weeks

Secondary Outcomes (10)

• Changes in GERD Questionnaire (GERDQ) sum scores

  4 and 8 weeks

• Composite heartburn and regurgitation response rate

  4 and 8 weeks

• Heartburn response rate

  4 and 8 weeks

• Regurgitation response rate

  4 and 8 weeks

• Overall response rate

  4 and 8 weeks

Study Arms (2)

Treatment 1

ACTIVE COMPARATOR

1 Omeprazole capsule 20 mg and 1 placebo caplet of DLBS2411, twice daily

Drug: Omeprazole; Drug: Placebo caplet of DLBS2411

Treatment II

EXPERIMENTAL

1 DLBS2411 caplet 250 mg and 1 placebo capsule of Omeprazole, twice daily

Drug: DLBS2411; Drug: Placebo capsule of Omeprazole

Interventions

Omeprazole DRUG

1 Omeprazole 20 mg capsules twice daily

Treatment 1

DLBS2411 DRUG

1 DLBS2411 caplet 250 mg, twice daily

Also known as: Redacid

Treatment II

Placebo capsule of Omeprazole DRUG

1 placebo capsule of omeprazole, twice daily

Treatment II

Placebo caplet of DLBS2411 DRUG

1 placebo caplet of DLBS2411, twice daily

Also known as: Placebo caplet of Redacid

Treatment 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (5)

Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Padjajaran Dr. Hasan Sadikin Hospital

Bandung, Indonesia

Location

Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital

Jakarta, 10430, Indonesia

Location

Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital

Semarang, Indonesia

Location

Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital

Surabaya, Indonesia

Location

Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital

Yogyakarta, Indonesia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 8, 2017
• Study Start: August 16, 2018
• Primary Completion: May 4, 2020
• Study Completion: September 9, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

ID (5)