Last reviewed · How we verify
NCT00164866
Administration of Intravenous Proton Pump Inhibitor Prior to Endoscopy [APPE] in Patients With Upper Gastrointestinal Bleeding; a Double-Blind Placebo-Controlled Randomised Study.
Phase 4 trial testing Omeprazole in Peptic Ulcer in 638 participants. Completed in 1 September 2005.
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 638 |
| Start date | 1 February 2004 |
| Estimated completion | 1 September 2005 |
| Sites | 1 location across China |
Drugs / interventions tested
- Omeprazole (omeprazole) — full drug profile →
Conditions studied
- Peptic Ulcer — all drugs for Peptic Ulcer →
Sponsor
Chinese University of Hong Kong
Who can join
16 and older, any sex, with Peptic Ulcer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- early intranvenous infusion of a high-dose poton-pump inhibitor before endoscopy would have a therapeutic effect on bleeding ulcers, reduce the need for endoscopic therapy, and result in improved clinical outcomes.
Sponsor's own description
To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding before endoscopy. These may translate into improved patients'outcome and survival. To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Omeprazole before endoscopy in patients with gastrointestinal bleeding.
Lau JY, Leung WK, Wu JC, Chan FK, et al · · 2007 · cited 179× · PMID 17442905 · DOI 10.1056/nejmoa065703 -
Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.
Kanno T, Yuan Y, Tse F, Howden CW, et al · · 2022 · cited 16× · PMID 34995368 · DOI 10.1002/14651858.cd005415.pub4
Verify or expand the search:
- PubMed search for NCT00164866
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Omeprazole
Trials testing the same drug.
- NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting
- NCT07223671 — Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy · Phase 1 · completed
- NCT07235748 — Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvas · Phase 1 · completed
- NCT07149415 — A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's S · Phase 1 · completed
- NCT06948006 — A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omepr · Phase 1 · completed
Other recruiting trials for Peptic Ulcer
Currently open trials in the same condition.
- NCT07260006 — Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Dis · NA · recruiting
- NCT06284876 — Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer · Phase 3 · recruiting
- NCT04702542 — To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children. · NA · active not recruiting
Other Chinese University of Hong Kong trials
Trials by the same sponsor.
- NCT07508644 — RSV Vaccination to Reduce Recurrent AECOPD · Phase 4 · not yet recruiting
- NCT07230457 — Plasma MTB cfDNA Before Bronchoscopy · not yet recruiting
- NCT07288671 — Nostalgia Intervention on Alleviating Loneliness Amongst Older Adults · NA · not yet recruiting
- NCT07256457 — Postoperative Pulmonary Function Assessment Based on Deep Learning Study · NA · not yet recruiting
- NCT06904209 — Can Artificial Intelligence Reduce Consumption of Standard High Volume Bowel Preparation Regimen Among Older Population, · NA · not yet 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 NCT00164866 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 5 June 2007
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/NCT00164866.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing