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NCT00164931
Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
Phase 3 trial testing Intravenous omeprazole infusion in Peptic Ulcer Hemorrhage in 240 participants. Completed.
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 October 2003 |
| Sites | 1 location across China |
Drugs / interventions tested
- Intravenous omeprazole infusion — full drug profile →
- Scheduled second endoscopy
Conditions studied
- Peptic Ulcer Hemorrhage — all drugs for Peptic Ulcer Hemorrhage →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 18 to 90, any sex, with Peptic Ulcer Hemorrhage. 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.
- Recurrent bleeding within 30 days after initial endoscopy defined as -
- Clinical criteria (anyone of the below)
- 1. Haemetmesis or fresh blood from Ryles tube
- 2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
- 3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
- 4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
Sponsor's own description
A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.
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 NCT00164931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00164931 (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 Chinese University of Hong Kong
- Last refreshed: 9 June 2011
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/NCT00164931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing