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NCT01118663 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
A Phase 3 study, sponsored by Cumberland Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 17
- Enrollment target
NCT01118663: Clinical Trial Phase 3 study, sponsored by Cumberland Pharmaceuticals.
NCT01118663 is a Phase 3 study that was terminated before completion, run by Cumberland Pharmaceuticals. The registered enrollment target is 17 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01118663, a Phase 3 study, was terminated before completion, sponsored by Cumberland Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.
Primary Outcome
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Interventions
- DRUG Acetadote
- DRUG Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
Why NCT01118663 stopped before completion
NCT01118663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetadote is the first listed.
NCT01118663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01118663 about?
NCT01118663 is a clinical study titled "Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection". The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.
What is the current status of trial NCT01118663?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 17 participants. The study started on 2010-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01118663?
The interventions under investigation include: Acetadote (DRUG), Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) (DRUG).
Who is sponsoring clinical trial NCT01118663?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01118663's enrollment target sits among peer trials
17 1971st of 2000 higher than 27 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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