Trial · NCT00842829
Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
NCT00842829, Phase 4, Terminated, Cephalon; results first posted 2012-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients. Trials, record NCT00842829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00842829
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
- NCT number
- NCT00842829
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 330 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Cancer Pain, Breakthrough Pain
- Interventions
- Fentanyl Buccal Tablet (FBT)
- First posted
- 2009-02-12
- Last updated
- 2012-10-01
- Other registries' IDs
- eudract:2008-001841-24
- Results first posted
- 2012-09-20
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period | Day 1 up to Day 7 | The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes. |
| Secondary | Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes | approximately Day 8-15 | Overall episode data analyzed all values of time to meaningful pain relief taken over all BTP episodes during the treatment period. If meaningful pain relief was not achieved within 60 minutes of FBT intake, or if rescue medication was taken, the event was censored. Meaningful pain relief was left to the judgment of participants, who used a stopwatch and recorded the time from treatment until pain relief in a patient diary. |
| Secondary | Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | Day 1 up to Day 7 | Number of participants for which an effective dose of FBT was reached as judged by each participant. The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes. |
| Secondary | Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period | Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period) | The number of breakthrough pain (BTP) episodes in which the participant did not obtain effective pain relief from study medication and took a rescue medication. |
| Secondary | Participant Assessment of Medication Performance During the Treatment Period | approximately Day 8-15 | Participants assessed the performance of FBT at 30 minutes and 60 minutes after dosing each episode during the treatment period. For each episode, the participant answered the question 'How well did your study medication perform in controlling the breakthrough pain episode?' on a 5-point Likert-type scale (poor=0, fair=1, good=2, very good=3, and excellent=4). |
| Secondary | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses general activity. |
| Secondary | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses mood. |
| Secondary | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses walking ability. |
| Secondary | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses normal work. |
| Secondary | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Relations With Other People | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement. This subscale assesses relations with other people. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period | Day 1 up to Day 7 | Titration safety analysis set consisting of participants who took at least one dose of study medication. | percentage of treated participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes | approximately Day 8-15 | Safety analysis set consisting of participants who received at least one dose of study drug during the Treatment Period, and who recorded the time to pain relief in the patient diary. | minutes | MEDIAN |
| SECONDARY | Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | Day 1 up to Day 7 | Titration safety analysis set consisting of participants who took at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period | Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period) | Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period. | BTP episodes | NUMBER |
| SECONDARY | Participant Assessment of Medication Performance During the Treatment Period | approximately Day 8-15 | Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose. | BTP episodes | NUMBER |
| SECONDARY | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with both baseline and Treatment Period responses | units on a scale | MEAN |
| SECONDARY | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with both baseline and Treatment Period responses | units on a scale | MEAN |
| SECONDARY | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with both baseline and Treatment Period responses | units on a scale | MEAN |
| SECONDARY | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with both baseline and Treatment Period responses | units on a scale | MEAN |
| SECONDARY | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Relations With Other People | Day 0 (baseline), approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with both baseline and Treatment Period responses | units on a scale | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period | FBT 100 Mcg - Dose Titration Period | 75.2 | percentage of treated participants | ||
| Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period | FBT 200 Mcg - Dose Titration Period | 81.2 | percentage of treated participants | ||
| Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes | FBT - Treatment Period | 19.00 | Inter-Quartile Range 12.00 to 30.00 | minutes | |
| Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | FBT 100 Mcg - Dose Titration Period | 100 mcg | 34 | participants | |
| Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | FBT 200 Mcg - Dose Titration Period | 100 mcg | 7 | participants | |
| Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | FBT 100 Mcg - Dose Titration Period | 200 mcg | 38 | participants | |
| Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | FBT 200 Mcg - Dose Titration Period | 200 mcg | 61 | participants | |
| Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | FBT 100 Mcg - Dose Titration Period | 300 mcg (evaluated by mistake) | 1 | participants | |
| Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | FBT 200 Mcg - Dose Titration Period | 300 mcg (evaluated by mistake) | 1 | participants | |
| Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period | FBT 100 Mcg - Dose Titration Period | 400 mcg | 23 | participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Titration Period | STARTED | FBT 100 Mcg - Dose Titration Period | 156 | |
| Dose Titration Period | STARTED | FBT 200 Mcg - Dose Titration Period | 174 | |
| Dose Titration Period | STARTED | FBT - Treatment and Continuation Periods | 0 | |
| Dose Titration Period | Titration Safety Analysis Set | FBT 100 Mcg - Dose Titration Period | 145 | |
| Dose Titration Period | Titration Safety Analysis Set | FBT 200 Mcg - Dose Titration Period | 167 | |
| Dose Titration Period | Titration Safety Analysis Set | FBT - Treatment and Continuation Periods | 0 | |
| Dose Titration Period | COMPLETED | FBT 100 Mcg - Dose Titration Period | 130 | |
| Dose Titration Period | COMPLETED | FBT 200 Mcg - Dose Titration Period | 151 | |
| Dose Titration Period | COMPLETED | FBT - Treatment and Continuation Periods | 0 | |
| Dose Titration Period | NOT COMPLETED | FBT 100 Mcg - Dose Titration Period | 26 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events83
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 | FBT - All Doses and Study Periods | 30 | 312 | |
| other | Vomiting | Gastrointestinal disorders | FBT - All Doses and Study Periods | 23 | 312 | |
| other | Somnolence | Nervous system disorders | FBT - All Doses and Study Periods | 16 | 312 | |
| serious | Anaemia | Blood and lymphatic system disorders | FBT - All Doses and Study Periods | 3 | 312 | |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | FBT - All Doses and Study Periods | 1 | 312 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | FBT - All Doses and Study Periods | 1 | 312 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | FBT - All Doses and Study Periods | 1 | 312 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | FBT - All Doses and Study Periods | 2 | 312 | |
| serious | Tachyarrhythmia | Cardiac disorders | FBT - All Doses and Study Periods | 1 | 312 | |
| serious | Cardiovascular insufficiency | Cardiac disorders | FBT - All Doses and Study Periods | 1 | 312 |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FBT - All Doses and Study Periods | ||
| Total, other adverse events | FBT - All Doses and Study Periods | 52 | 312 |
| Total, serious adverse events | FBT - All Doses and Study Periods | 67 | 312 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00842829
GET https://conductscience.org/api/trials/v1/NCT00842829/registered?page=2