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NCT01798589 · ClinicalTrials.gov registry record · Phase 4
Bioequivalence of Ethylenediamine Dihydrochloride Study
A Phase 4 study, sponsored by Allerderm.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT01798589: Completed Phase 4 study, sponsored by Allerderm.
NCT01798589 is a Phase 4 study that has completed, run by Allerderm. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01798589, a Phase 4 study, has completed, sponsored by Allerderm.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
Primary Outcome
Bioequivalence will be calculated using concordance (Cohen's Kappa) between the number of subjects with positive reactions (defined as a score of 1+, 2+ or 3+) to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and the number of subjects with negative reactions to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolid
Interventions
- DRUG Ethylenediamine dihydrochloride allergen patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
What the finished NCT01798589 record still lists
NCT01798589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Ethylenediamine dihydrochloride allergen patch is the first listed.
NCT01798589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01798589 about?
NCT01798589 is a clinical study titled "Bioequivalence of Ethylenediamine Dihydrochloride Study". The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
What is the current status of trial NCT01798589?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2012-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01798589?
The interventions under investigation include: Ethylenediamine dihydrochloride allergen patch (DRUG).
Who is sponsoring clinical trial NCT01798589?
This trial is sponsored by Allerderm, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01798589's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 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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