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NCT03367195
Efficacy and Safety of DLBS2411 in the Management of GERD
Phase 3 trial testing Omeprazole in Gastroesophageal Reflux Disease (GERD) in 32 participants. Terminated before completion.
4 May 2020
Quick facts
| Lead sponsor | Dexa Medica Group |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 16 August 2018 |
| Primary completion | 4 May 2020 |
| Estimated completion | 9 September 2020 |
| Sites | 5 locations across Indonesia |
Drugs / interventions tested
- Omeprazole (omeprazole) — full drug profile →
- DLBS2411 — full drug profile →
- Placebo capsule of Omeprazole — full drug profile →
- Placebo caplet of DLBS2411 — full drug profile →
Conditions studied
- Gastroesophageal Reflux Disease (GERD) — all drugs for Gastroesophageal Reflux Disease (GERD) →
Sponsor
Dexa Medica Group — full company profile →
Who can join
Adults 18 to 65, any sex, with Gastroesophageal Reflux Disease (GERD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03367195
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Currently open trials in the same condition.
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Other Dexa Medica Group trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03367195 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dexa Medica Group
- Last refreshed: 7 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03367195.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing