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NCT01378520 · ClinicalTrials.gov registry record · Phase 4
Effect of Ketoconazole on Breathlessness
A Phase 4 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01378520: Completed Phase 4 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01378520 is a Phase 4 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378520, a Phase 4 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce ratings of breathlessness induced by resistive breathing loads.
Primary Outcome
The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for unpleasantness through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder. Subject
Interventions
- DRUG ketoconazole
- DRUG inert powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT01378520 record still lists
NCT01378520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which ketoconazole is the first listed.
NCT01378520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378520 about?
NCT01378520 is a clinical study titled "Effect of Ketoconazole on Breathlessness". Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce ratings of breathlessness ...
What is the current status of trial NCT01378520?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2011-06. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01378520?
The interventions under investigation include: ketoconazole (DRUG), inert powder (DRUG).
Who is sponsoring clinical trial NCT01378520?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01378520's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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