Trial · NCT00463047
Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
NCT00463047, Phase 3, Completed, Cephalon; results first posted 2010-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain. Trials, record NCT00463047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00463047
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
- NCT number
- NCT00463047
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 323 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Chronic Pain
- Interventions
- Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
- First posted
- 2007-04-19
- Last updated
- 2012-05-28
- Results first posted
- 2010-12-14
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity Difference (PID15) At 15 Minutes | Immediately pre-dose and fifteen minutes after administration of study drug | 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 sequence as fixed factors and patient as a random factor using compound symmetry. |
| Secondary | Pain Intensity Difference (PID 5) at 5 Minutes | Immediately before and 5 minutes after study drug administration | 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 PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Secondary | Pain Intensity Difference (PID 10) at 10 Minutes | Immediately before and 10 minutes after administration of study drug | 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 PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Secondary | Pain Intensity Difference (PID 30) at 30 Minutes | Immediately before and 10 minutes after study drug administration | 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 PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Secondary | Pain Intensity Difference (PID 45) at 45 Minutes | Immediately before and 45 minutes after study drug administration | 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 PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Secondary | Pain Intensity Difference (PID 60) at 60 Minutes | Immediately before and 60 minutes after administration of study drug | 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 PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. |
| Secondary | Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment | Immediately before and 5 minutes after administration of study drug | 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 PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100. |
| Secondary | Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes | Immediately before and 10 minutes after study drug administration | 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 PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100. |
| Secondary | Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes | Immediately before and 15 minutes after administration of study drug | 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. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100. |
| Secondary | Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes | Immediately before and 30 minutes after study drug administration | 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 PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Intensity Difference (PID15) At 15 Minutes | Immediately pre-dose and fifteen minutes after administration of study drug | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference (PID 5) at 5 Minutes | Immediately before and 5 minutes after study drug administration | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference (PID 10) at 10 Minutes | Immediately before and 10 minutes after administration of study drug | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference (PID 30) at 30 Minutes | Immediately before and 10 minutes after study drug administration | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference (PID 45) at 45 Minutes | Immediately before and 45 minutes after study drug administration | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference (PID 60) at 60 Minutes | Immediately before and 60 minutes after administration of study drug | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment | Immediately before and 5 minutes after administration of study drug | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Percent change in units on a scale | MEAN |
| SECONDARY | Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes | Immediately before and 10 minutes after study drug administration | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Percentage change in units on a scale | MEAN |
| SECONDARY | Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes | Immediately before and 15 minutes after administration of study drug | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Percent change in units on a scale | MEAN |
| SECONDARY | Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes | Immediately before and 30 minutes after study drug administration | Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores. | Percent change in units on a scale | MEAN |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Intensity Difference (PID15) At 15 Minutes | Fentanyl Buccal Tablets (FBT) | 0.82 | Standard Error 0.07 | Units on a scale | |
| Pain Intensity Difference (PID15) At 15 Minutes | Immediate-Release Oxycodone | 0.59 | Standard Error 0.07 | Units on a scale | |
| Pain Intensity Difference (PID 5) at 5 Minutes | Fentanyl Buccal Tablets (FBT) | 0.08 | Standard Error 0.03 | Units on a scale | |
| Pain Intensity Difference (PID 5) at 5 Minutes | Immediate-Release Oxycodone | 0.05 | Standard Error 0.03 | Units on a scale | |
| Pain Intensity Difference (PID 10) at 10 Minutes | Fentanyl Buccal Tablets (FBT) | 0.30 | Standard Error 0.04 | Units on a scale | |
| Pain Intensity Difference (PID 10) at 10 Minutes | Immediate-Release Oxycodone | 0.22 | Standard Error 0.04 | Units on a scale | |
| Pain Intensity Difference (PID 30) at 30 Minutes | Fentanyl Buccal Tablets (FBT) | 1.96 | Standard Error 0.09 | Units on a scale | |
| Pain Intensity Difference (PID 30) at 30 Minutes | Immediate-Release Oxycodone | 1.58 | Standard Error 0.09 | Units on a scale | |
| Pain Intensity Difference (PID 45) at 45 Minutes | Fentanyl Buccal Tablets (FBT) | 2.87 | Standard Error 0.12 | Units on a scale | |
| Pain Intensity Difference (PID 45) at 45 Minutes | Immediate-Release Oxycodone | 2.59 | Standard Error 0.12 | Units on a scale |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Period 1 | STARTED | FBT First Immediate Release Oxycodone Second | 160 | |
| Titration Period 1 | STARTED | Immediate-Release Oxycodone First FBT Second | 160 | |
| Titration Period 1 | COMPLETED | FBT First Immediate Release Oxycodone Second | 123 | |
| Titration Period 1 | COMPLETED | Immediate-Release Oxycodone First FBT Second | 121 | |
| Titration Period 1 | NOT COMPLETED | FBT First Immediate Release Oxycodone Second | 37 | |
| Titration Period 1 | NOT COMPLETED | Immediate-Release Oxycodone First FBT Second | 39 | |
| Titration Period 2 | STARTED | FBT First Immediate Release Oxycodone Second | 123 | |
| Titration Period 2 | STARTED | Immediate-Release Oxycodone First FBT Second | 121 | |
| Titration Period 2 | COMPLETED | FBT First Immediate Release Oxycodone Second | 93 | |
| Titration Period 2 | COMPLETED | Immediate-Release Oxycodone First FBT Second | 98 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Fentanyl Buccal Tablets (FBT) | 26 | 281 | |
| other | Nausea | Gastrointestinal disorders | Immediate-Release Oxycodone | 11 | 284 | |
| other | Diarrhea | Gastrointestinal disorders | Fentanyl Buccal Tablets (FBT) | 6 | 281 | |
| other | Diarrhea | Gastrointestinal disorders | Immediate-Release Oxycodone | 3 | 284 | |
| other | Vomiting | Gastrointestinal disorders | Fentanyl Buccal Tablets (FBT) | 4 | 281 | |
| other | Vomiting | Gastrointestinal disorders | Immediate-Release Oxycodone | 3 | 284 | |
| other | Constipation | Gastrointestinal disorders | Fentanyl Buccal Tablets (FBT) | 1 | 281 | |
| other | Constipation | Gastrointestinal disorders | Immediate-Release Oxycodone | 4 | 284 | |
| other | Dry mouth | Gastrointestinal disorders | Fentanyl Buccal Tablets (FBT) | 1 | 281 | |
| other | Dry mouth | Gastrointestinal disorders | Immediate-Release Oxycodone | 3 | 284 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fentanyl Buccal Tablets (FBT) | ||
| Total, all-cause mortality | Immediate-Release Oxycodone | ||
| Total, other adverse events | Fentanyl Buccal Tablets (FBT) | 79 | 281 |
| Total, other adverse events | Immediate-Release Oxycodone | 49 | 284 |
| Total, serious adverse events | Fentanyl Buccal Tablets (FBT) | 1 | 281 |
| Total, serious adverse events | Immediate-Release Oxycodone | 0 | 284 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fentanyl Buccal Tablets (FBT) vs Immediate-Release Oxycodone: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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