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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: Completed Phase 3 study of Pain, Postoperative, sponsored by Bayer.
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 113 other Pain, Postoperative trials with a reported enrollment target (11% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain r
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 |
What the finished NCT01389284 record still lists
NCT01389284 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 270-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (11% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pain, Postoperative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01389284's enrollment target sits among peer trials
300 11th of 113 higher than 103 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative 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.
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