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NCT00751400 · ClinicalTrials.gov registry record · Phase 3
Naproxen Sodium Extended-Release Actual Use Study
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 497
- Enrollment target
NCT00751400: Completed Phase 3 study, sponsored by Bayer.
NCT00751400 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 497 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00751400, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 497 participants
- Enrollment target
Study Summary
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Primary Outcome
Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expressi
Interventions
- DRUG Naproxen Sodium ER (BAYH6689)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2008-07 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
What the finished NCT00751400 record still lists
NCT00751400 is an interventional study that assigns participants to a tested intervention. The registered 497 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 1 intervention - of which Naproxen Sodium ER (BAYH6689) is the first listed.
NCT00751400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00751400 about?
NCT00751400 is a clinical study titled "Naproxen Sodium Extended-Release Actual Use Study". The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
What is the current status of trial NCT00751400?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 497 participants. The study started on 2008-07. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00751400?
The interventions under investigation include: Naproxen Sodium ER (BAYH6689) (DRUG).
Who is sponsoring clinical trial NCT00751400?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00751400's enrollment target sits among peer trials
497 775th of 2000 higher than 1,225 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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