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NCT01241513 · ClinicalTrials.gov registry record · Phase 4
Induced Changes in Ventilatory Responsiveness and Altitude Exposure
A Phase 4 study, sponsored by United States Army Research Institute of Environmental Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT01241513: Clinical Trial Phase 4 study, sponsored by United States Army Research Institute of Environmental Medicine.
NCT01241513 is a Phase 4 study that was terminated before completion, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 21 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
NCT01241513, a Phase 4 study, was terminated before completion, sponsored by United States Army Research Institute of Environmental Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is approved by the Food and Drug Administration (FDA) as a treatment or antidote for Tylenol overdoses. Other forms of ACCY are also sold over-the-counter as nutritional supplements. In this study, the FDA-approved form of ACCY will be used "off-label" (meaning in a way not approved by the FDA). This study is being conducted by researchers from the United States Army Research Institute of Environmental Medicine (USARIEM). The study will take place in the Altitude Chamber located in the basement of USARIEM. A total of approximately 30 volunteers (men and women, military and civilians) will take part in the study. They can expect to be in the study for a minimum of a few hours each day for two weeks. The investigators hypothesize that ACCY will improve ventilation and oxygenation while at altitude.
Primary Outcome
Finger Pulse Oximetry to measure arterial oxygen saturation
Interventions
- DRUG Placebo
- DRUG NAC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-11-01 |
| Est. Completion | 2013-02-28 |
| Phase | Phase 4 |
Why NCT01241513 stopped before completion
NCT01241513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 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 Placebo is the first listed.
NCT01241513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01241513 about?
NCT01241513 is a clinical study titled "Induced Changes in Ventilatory Responsiveness and Altitude Exposure". The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is approved by the Food and Drug Administration (FDA) as a treatment or antidote for Tylenol overdoses. Other forms of ACCY are al...
What is the current status of trial NCT01241513?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2010-11-01. Estimated completion is 2013-02-28.
What interventions are being tested in trial NCT01241513?
The interventions under investigation include: Placebo (DRUG), NAC (DRUG).
Who is sponsoring clinical trial NCT01241513?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01241513's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 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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