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NCT00720057 · ClinicalTrials.gov registry record · Phase 3
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
A Phase 3 study of Toothache, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
- 3
- Study locations
NCT00720057: Completed Phase 3 study of Toothache, sponsored by Bayer.
NCT00720057 is a Phase 3 study of Toothache that has completed, run by Bayer. The registered enrollment target is 312 participants, above the 61-participant average among 3 other Toothache trials with a reported enrollment target (411% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00720057, a Phase 3 study of Toothache, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
- 3
- Study locations
Study Summary
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
Primary Outcome
Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naproxen Sodium ER (BAYH6689)
Study Locations (3)
Texas
- - Austin
- - Austin
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00720057 record still lists
NCT00720057 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 61-participant average among 3 other Toothache trials with a reported enrollment target (411% higher).
The record links to 1 condition, with Toothache appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00720057 reports a single indexed study location in Texas, Utah.
Frequently Asked Questions
What is clinical trial NCT00720057 about?
NCT00720057 is a clinical study titled "Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.". To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
What is the current status of trial NCT00720057?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2008-06. Estimated completion is 2008-08.
What conditions does trial NCT00720057 study?
This clinical trial studies the following conditions: Toothache.
What interventions are being tested in trial NCT00720057?
The interventions under investigation include: Placebo (DRUG), Naproxen Sodium ER (BAYH6689) (DRUG).
Who is sponsoring clinical trial NCT00720057?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00720057 being conducted?
This trial has 3 study locations across Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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