NCT00132405 is a Phase 2 clinical trial of ALGRX 3268 in Pain, sponsored by AlgoRx Pharmaceuticals.

Who is sponsoring NCT00132405?

NCT00132405 is sponsored by AlgoRx Pharmaceuticals.

What drugs are being tested in NCT00132405?

Interventions in NCT00132405: ALGRX 3268.

Is NCT00132405 still recruiting?

NCT00132405 is currently completed. Last updated 7 October 2005.

Last reviewed 2005-10-07 · How we verify

NCT00132405

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effectiveness and Safety of ALGRX 3268 0.5 Mg/20 Bar at the Back of the Hand in Pediatric Subjects

Completed Phase 2 Last updated 7 October 2005

What this trial tests

Phase 2 trial testing ALGRX 3268 in Pain in 260 participants. Completed in 1 September 2004.

Timeline

1 May 2004

1 September 2004

Quick facts

Lead sponsor	AlgoRx Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	260
Start date	1 May 2004
Estimated completion	1 September 2004
Sites	1 location across United States

Drugs / interventions tested

ALGRX 3268 — full drug profile →

Conditions studied

Pain — all drugs for Pain →

Sponsor

AlgoRx Pharmaceuticals — full company profile →

Who can join

Adults 3 to 18, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Subject's assessment of the pain of venipuncture following administration of study treatment

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00132405 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AlgoRx Pharmaceuticals
Last refreshed: 7 October 2005

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00132405.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing