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NCT02597478 · ClinicalTrials.gov registry record · Phase 2
Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02597478: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02597478 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02597478, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.
Primary Outcome
The primary outcome was dyspnea intensity "now" using the modified Borg scale, which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. This scale has been validated in multiple studies, with a minimal clinically significant difference of 1 point.
Interventions
- BEHAVIORAL Questionnaires
- BEHAVIORAL Phone Call
- DRUG Fentanyl Sublingual Spray
- PROCEDURE Shuttle Walk Test
- BEHAVIORAL Mental Ability Tests
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-01-04 |
| Est. Completion | 2021-01-27 |
| Phase | Phase 2 |
What the finished NCT02597478 record still lists
NCT02597478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Questionnaires is the first listed.
NCT02597478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02597478 about?
NCT02597478 is a clinical study titled "Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea". The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.
What is the current status of trial NCT02597478?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2016-01-04. Estimated completion is 2021-01-27.
What interventions are being tested in trial NCT02597478?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Phone Call (BEHAVIORAL), Fentanyl Sublingual Spray (DRUG), Shuttle Walk Test (PROCEDURE), Mental Ability Tests (BEHAVIORAL).
Who is sponsoring clinical trial NCT02597478?
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 NCT02597478's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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