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NCT00132405 · ClinicalTrials.gov registry record · Phase 2
Study of ALGRX 3268 for Needlestick Pain in Children
A Phase 2 study, sponsored by AlgoRx Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
NCT00132405 is a Phase 2 study that has completed, run by AlgoRx Pharmaceuticals. The registered enrollment target is 260 participants.
The verdict
NCT00132405, a Phase 2 study, has completed, sponsored by AlgoRx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
Study Summary
Minor needlestick procedures often cause significant pain and distress in children, yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free dispenser that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2 to 3 minutes. The purpose of this prospective, randomized, double-blind, and placebo-controlled trial is to determine the efficacy and tolerability of ALGRX 3268 in children aged 3 to 18 years undergoing venipuncture. The trial will enroll a total of 306 children aged 3 to 18 years scheduled to undergo venipuncture of the back of the hand at a single study center.
Interventions
- DRUG ALGRX 3268
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2004-05 |
| Est. Completion | 2004-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00132405
The ClinicalTrials.gov registry entry for NCT00132405 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 260 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.
NCT00132405 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00132405 about?
NCT00132405 is a clinical study titled "Study of ALGRX 3268 for Needlestick Pain in Children". Minor needlestick procedures often cause significant pain and distress in children, yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free dispenser that immediately delivers powdered lidocaine into the epidermis and provides local analgesia...
What is the current status of trial NCT00132405?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2004-05. Estimated completion is 2004-09.
What interventions are being tested in trial NCT00132405?
The interventions under investigation include: ALGRX 3268 (DRUG).
Who is sponsoring clinical trial NCT00132405?
This trial is sponsored by AlgoRx Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
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