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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 is a Phase 3 study that has completed, run by AlgoRx Pharmaceuticals. The registered enrollment target is 504 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00146185
The ClinicalTrials.gov registry entry for NCT00146185 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 504 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AlgoRx Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ALGRX 3268 is the first listed.
NCT00146185 reports 0 study locations.
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.
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