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NCT01689363 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 253
- Enrollment target
NCT01689363: Completed Phase 2 study, sponsored by Amphastar Pharmaceuticals.
NCT01689363 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 253 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01689363, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 253 participants
- Enrollment target
Study Summary
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
Primary Outcome
Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (\>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.
Interventions
- DRUG Saline
- DRUG Histamine
- DRUG Hyaluronidase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01689363 record still lists
NCT01689363 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 3 interventions - of which Saline is the first listed.
NCT01689363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01689363 about?
NCT01689363 is a clinical study titled "Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)". This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
What is the current status of trial NCT01689363?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 253 participants. The study started on 2012-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01689363?
The interventions under investigation include: Saline (DRUG), Histamine (DRUG), Hyaluronidase (DRUG).
Who is sponsoring clinical trial NCT01689363?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01689363's enrollment target sits among peer trials
253 220th of 2000 higher than 1,781 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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