Last reviewed · How we verify
NCT04359966
Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia
NA trial testing Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg, in Helicobacter Pylori Infection in 560 participants. Status unknown.
31 May 2023
Quick facts
| Lead sponsor | Slovenian Society for Gastroenterology and Hepatology |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 560 |
| Start date | 10 May 2020 |
| Primary completion | 31 May 2023 |
| Estimated completion | 30 September 2023 |
| Sites | 3 locations across Slovenia |
Drugs / interventions tested
- Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg, — full drug profile →
- Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg — full drug profile →
- Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg — full drug profile →
- Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg — full drug profile →
Conditions studied
- Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →
- Eradication Treatments — all drugs for Eradication Treatments →
Sponsor
Slovenian Society for Gastroenterology and Hepatology
Who can join
Adults 18 to 80, any sex, with Helicobacter Pylori Infection or Eradication Treatments. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04359966
- 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
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 NCT04359966 (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 Slovenian Society for Gastroenterology and Hepatology
- Last refreshed: 24 April 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/NCT04359966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing