A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects.
Sponsor study identifier
interventional
504
1 country
1
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 31, 2005
Actual (reported)September 1, 2005
Actual (reported)Child's rating of pain on venipuncture following administration of the study treatment.
Evaluation of pain due to venipuncture in each age group 3-7, 8-12 and 13-18.
Parent/legal guardian's rating of child's pain on an 100 VAS.
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Schmitz ML, Zempsky WT, Meyer JM. Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial. Clin Ther. 2015 Aug;37(8):1761-72. doi: 10.1016/j.clinthera.2015.05.515. Epub 2015 Jul 8.
Zempsky WT, Bean-Lijewski J, Kauffman RE, Koh JL, Malviya SV, Rose JB, Richards PT, Gennevois DJ. Needle-free powder lidocaine delivery system provides rapid effective analgesia for venipuncture or cannulation pain in children: randomized, double-blind Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment trial. Pediatrics. 2008 May;121(5):979-87. doi: 10.1542/peds.2007-0814.
William Zempsky, MD
Connecticut Childrne's Medical Center
First Submitted
August 31, 2005
First Posted
September 1, 2005
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
April 2005
Date type not reportedSkin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
September 1, 2005
Record last verified: 2005-08
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