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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00137033
The ClinicalTrials.gov registry entry for NCT00137033 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 605 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Celecoxib is the first listed.
NCT00137033 reports 0 study locations.
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.
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