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NCT01832402 · ClinicalTrials.gov registry record · Phase 2
Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01832402: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01832402 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832402, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer. Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well. In this study, fentanyl will be compared to a placebo. 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 of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
Interventions
- BEHAVIORAL Questionnaires
- DRUG Placebo Nasal Spray
- OTHER Walk Test
- BEHAVIORAL Mental Ability Tests
- DRUG Fentanyl Pectin Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-06-11 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 2 |
What the finished NCT01832402 record still lists
NCT01832402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 5 interventions - of which Questionnaires is the first listed.
NCT01832402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832402 about?
NCT01832402 is a clinical study titled "Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea". The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer. Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well...
What is the current status of trial NCT01832402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2013-06-11. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT01832402?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Placebo Nasal Spray (DRUG), Walk Test (OTHER), Mental Ability Tests (BEHAVIORAL), Fentanyl Pectin Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT01832402?
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 NCT01832402's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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