Trial · NCT00842829
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep | 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: Enjoyment of Life | 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: Global Score | 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 | Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period | approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with a response | participants | NUMBER |
| SECONDARY | Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period | approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with a response | participants | NUMBER |
| SECONDARY | Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period | approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with a response | participants | NUMBER |
| SECONDARY | Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period | approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with a response | participants | NUMBER |
| SECONDARY | Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period | approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with a response | participants | NUMBER |
| SECONDARY | Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period | approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with a response | participants | NUMBER |
| SECONDARY | Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period | approximately Day 15 (end of Treatment Period) | Safety analysis set of participants with a response | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00842829/outcomes