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NCT01856114 · ClinicalTrials.gov registry record · Phase 2
Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01856114: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01856114 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01856114, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if fentanyl can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly used for treatment of cancer pain. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Primary Outcome
Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference between the baseline and second 6 minute walk test. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
Interventions
- BEHAVIORAL Questionnaires
- DRUG Fentanyl Buccal Tablet
- OTHER Placebo Buccal Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-05-27 |
| Est. Completion | 2019-12-04 |
| Phase | Phase 2 |
What the finished NCT01856114 record still lists
NCT01856114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Questionnaires is the first listed.
NCT01856114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01856114 about?
NCT01856114 is a clinical study titled "Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea". The goal of this clinical research study is to learn if fentanyl can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly ...
What is the current status of trial NCT01856114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2014-05-27. Estimated completion is 2019-12-04.
What interventions are being tested in trial NCT01856114?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Fentanyl Buccal Tablet (DRUG), Placebo Buccal Tablet (OTHER).
Who is sponsoring clinical trial NCT01856114?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01856114's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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