Last reviewed · How we verify
NCT03498456
Triple Therapy With Tegoprazan in H. Pylori Positive Patients
Phase 3 trial testing Tegoprazan/Amoxicillin/Clarithromycin in Helicobacter Pylori Infection in 284 participants. Completed in 31 December 2019.
31 December 2019
Quick facts
| Lead sponsor | HK inno.N Corporation |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 284 |
| Start date | 28 June 2018 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Tegoprazan/Amoxicillin/Clarithromycin — full drug profile →
- Lansoprazole/Amoxicillin/Clarithromycin — full drug profile →
Conditions studied
- Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →
Sponsor
HK inno.N Corporation — full company profile →
Who can join
Adults 20 to 75, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03498456
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Helicobacter Pylori Infection
Currently open trials in the same condition.
- NCT07285096 — P-CABs-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication · recruiting
- NCT07358130 — Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy · NA · recruiting
- NCT07165444 — Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatme · NA · recruiting
- NCT06929962 — VA Dual Sequential Therapy · Phase 4 · recruiting
- NCT06959368 — Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication · Phase 4 · recruiting
Other HK inno.N Corporation trials
Trials by the same sponsor.
- NCT07277712 — A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers · Phase 1 · not yet recruiting
- NCT07192263 — Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes M · Phase 3 · not yet recruiting
- NCT06736912 — This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of · Phase 1 · not yet recruiting
- NCT06725355 — To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adul · Phase 1 · active not recruiting
- NCT06332638 — PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects · Phase 1 · unknown
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 NCT03498456 (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 HK inno.N Corporation
- Last refreshed: 8 May 2020
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/NCT03498456.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing