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NCT00140088 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.
A Phase 3 study, sponsored by AlgoRx Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
NCT00140088 is a Phase 3 study that has completed, run by AlgoRx Pharmaceuticals. The registered enrollment target is 504 participants.
The verdict
NCT00140088, 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 | 2004-12 |
| Est. Completion | 2005-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00140088
The ClinicalTrials.gov registry entry for NCT00140088 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.
NCT00140088 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00140088 about?
NCT00140088 is a clinical study titled "Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.". 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 NCT00140088?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2004-12. Estimated completion is 2005-04.
What interventions are being tested in trial NCT00140088?
The interventions under investigation include: ALGRX 3268 (DRUG).
Who is sponsoring clinical trial NCT00140088?
This trial is sponsored by AlgoRx Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
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