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NCT00463047 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
A Phase 3 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
NCT00463047: Completed Phase 3 study, sponsored by Cephalon.
NCT00463047 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 323 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00463047, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
Study Summary
Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.
Primary Outcome
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and
Interventions
- DRUG Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00463047 record still lists
NCT00463047 is an interventional study that assigns participants to a tested intervention. The registered 323 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 (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone is the first listed.
NCT00463047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00463047 about?
NCT00463047 is a clinical study titled "Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain". Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.
What is the current status of trial NCT00463047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2007-07. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00463047?
The interventions under investigation include: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone (DRUG).
Who is sponsoring clinical trial NCT00463047?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00463047's enrollment target sits among peer trials
323 1081st of 2000 higher than 920 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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