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NCT01389284 · ClinicalTrials.gov registry record · Phase 3
Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
A Phase 3 study of Pain, Postoperative, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT01389284 is a Phase 3 study of Pain, Postoperative that has completed, run by Bayer. The registered enrollment target is 300 participants, above the 270-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (11% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01389284, a Phase 3 study of Pain, Postoperative, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.
Conditions Studied
Interventions
- DRUG Naproxen Sodium ER (BAYH6689)
- DRUG Naproxen Sodium IR (Aleve, BAYH6689)
- DRUG Naproxen Sodium ER Placebo
- DRUG Naproxen Sodium IR Placebo
Study Locations (1)
Texas
- - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01389284
The ClinicalTrials.gov registry entry for NCT01389284 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 270-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (11% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 4 interventions - of which Naproxen Sodium ER (BAYH6689) is the first listed.
NCT01389284 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01389284 about?
NCT01389284 is a clinical study titled "Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium". The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.
What is the current status of trial NCT01389284?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2011-06. Estimated completion is 2011-09.
What conditions does trial NCT01389284 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT01389284?
The interventions under investigation include: Naproxen Sodium ER (BAYH6689) (DRUG), Naproxen Sodium IR (Aleve, BAYH6689) (DRUG), Naproxen Sodium ER Placebo (DRUG), Naproxen Sodium IR Placebo (DRUG).
Who is sponsoring clinical trial NCT01389284?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01389284 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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