Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00137033 · ClinicalTrials.gov registry record · Phase 4
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 605
- Enrollment target
NCT00137033: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00137033 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 605 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00137033, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 605 participants
- Enrollment target
Study Summary
The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).
Interventions
- DRUG Celecoxib
- DRUG Naproxen
- DRUG ASA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 605 participants |
| Start Date | 2004-09 |
| Est. Completion | 2005-07 |
| Phase | Phase 4 |
What the finished NCT00137033 record still lists
NCT00137033 is an interventional study that assigns participants to a tested intervention. The registered 605 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which Celecoxib is the first listed.
NCT00137033 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00137033 about?
NCT00137033 is a clinical study titled "Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population". The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditi...
What is the current status of trial NCT00137033?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 605 participants. The study started on 2004-09. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00137033?
The interventions under investigation include: Celecoxib (DRUG), Naproxen (DRUG), ASA (DRUG).
Who is sponsoring clinical trial NCT00137033?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00137033's enrollment target sits among peer trials
605 137th of 2000 higher than 1,864 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02342444 · 606 participants · Phase 4
Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)
- NCT03849443 · 604 participants · Early Phase 1
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
- NCT05238922 · 604 participants · Phase 1
Study of INCB123667 in Subjects With Advanced Solid Tumors
- NCT06040541 · 604 participants · Phase 1
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia