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NCT00146185 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures.
A Phase 3 study, sponsored by AlgoRx Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
NCT00146185: Completed Phase 3 study, sponsored by AlgoRx Pharmaceuticals.
NCT00146185 is a Phase 3 study that has completed, run by AlgoRx Pharmaceuticals. The registered enrollment target is 504 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00146185, a Phase 3 study, has completed, sponsored by AlgoRx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 504 participants
- Enrollment target
Study Summary
Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III, prospective, randomized, double-blind, placebo-controlled study is to investigate the efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3 to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial will enroll approximate 504 evaluable subjects at centers located in the US.
Interventions
- DRUG ALGRX 3268
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2005-02 |
| Est. Completion | 2005-07 |
| Phase | Phase 3 |
What the finished NCT00146185 record still lists
NCT00146185 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which ALGRX 3268 is the first listed.
NCT00146185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00146185 about?
NCT00146185 is a clinical study titled "Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures.". Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local an...
What is the current status of trial NCT00146185?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2005-02. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00146185?
The interventions under investigation include: ALGRX 3268 (DRUG).
Who is sponsoring clinical trial NCT00146185?
This trial is sponsored by AlgoRx Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00146185's enrollment target sits among peer trials
504 742nd of 2000 higher than 1,258 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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