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NCT00954356 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
A Phase 2 study of Dental Pain, sponsored by Xenon Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT00954356: Completed Phase 2 study of Dental Pain, sponsored by Xenon Pharmaceuticals.
NCT00954356 is a Phase 2 study of Dental Pain that has completed, run by Xenon Pharmaceuticals. The registered enrollment target is 61 participants, below the 235-participant average among 6 other Dental Pain trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00954356, a Phase 2 study of Dental Pain, has completed, sponsored by Xenon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.
Primary Outcome
The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule. The higher the LS Means scores, the more pain relief was obtained. Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complet
Conditions Studied
Interventions
- DRUG placebo
- DRUG XPF-001
Study Locations (1)
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2009-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00954356 record still lists
NCT00954356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 235-participant average among 6 other Dental Pain trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Dental Pain appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00954356 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT00954356 about?
NCT00954356 is a clinical study titled "Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction". The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.
What is the current status of trial NCT00954356?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2009-09. Estimated completion is 2009-12.
What conditions does trial NCT00954356 study?
This clinical trial studies the following conditions: Dental Pain.
What interventions are being tested in trial NCT00954356?
The interventions under investigation include: placebo (DRUG), XPF-001 (DRUG).
Who is sponsoring clinical trial NCT00954356?
This trial is sponsored by Xenon Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00954356 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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