Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146185
Status:
COMPLETED
Last Update Posted:
2005-11-16
First Post:
2005-09-04
Brief Title:
Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures
Sponsor:
AlgoRx Pharmaceuticals
Organization:
AlgoRx Pharmaceuticals
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects
Status:
COMPLETED
Status Verified Date:
2005-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Pain management due to minor procedures such as venipuncture or peripheral venous canulation still represents an unmet medical need especially in pediatric setting Current therapeutic products have a relatively delayed onset of analgesia of at least 10 minutes moreover the most used products require application with at least 30-60 minutes prior to procedure Development of ALGRX 3268 is aimed at addressing this unmet need in management of pain associated with needlestick procedures
ALGRX 3268 Previously known as PowderJectR Dermal Lidocaine is used for local anesthesia within 3 minutes to provide painless needle or cathether insertion for blood drawing ALGRX 3268 is a single-use disposable system incorporating a drug cassette and cylinder into a single hand held device with a button to actuate the system
The purpose of this phase III multicenter prospective randomized double-blind placebo-controlled study is to investigate the efficacy safety and tolerability of ALGRX 3268 versus placebo in pediatric patients 3 to 18 years of age who undergo venipuncture or peripheral venous canulation procedures The trial will enroll approximate 504 evaluable subjects at centers located in the US
Three age groups are enrolled 3-7 years 8-12 years 13-18 years Within each age group subjects are randomized to receive ALGRX 3268 05 mg20 bar or pressure matched placebo One to 3 minutes after administration of study treatment at the back of the hand or antecubital fosa venipuncture is performed with a needleVacutainer needlesyringe or butterfly at the discretion of the investigator
Subjects 3-18 years are asked to assess pain on venipuncture using Wong-Baker FACES pain rating scale anchored at 0 for no hurt and 5 for hurts worst
Children in the middle 8-12 and older 13-18 age groups will additionally rate pain at the ACF and BOH using a 100 mm VAS anchored at 0 for no pain and at 100 for extreme pain Parentlegal guardian will evaluate childs level of pain on a 100 mm VAS anchored at 0 for no pain and at 100 for extreme pain
Safety ratings of skin are completed immediately prior after at 15 and 30 minutes following the procedure All AEsSAEs will be monitored
ALGRX 3268 Previously known as PowderJectR Dermal Lidocaine is used for local anesthesia within 3 minutes to provide painless needle or cathether insertion for blood drawing ALGRX 3268 is a single-use disposable system incorporating a drug cassette and cylinder into a single hand held device with a button to actuate the system
The purpose of this phase III multicenter prospective randomized double-blind placebo-controlled study is to investigate the efficacy safety and tolerability of ALGRX 3268 versus placebo in pediatric patients 3 to 18 years of age who undergo venipuncture or peripheral venous canulation procedures The trial will enroll approximate 504 evaluable subjects at centers located in the US
Three age groups are enrolled 3-7 years 8-12 years 13-18 years Within each age group subjects are randomized to receive ALGRX 3268 05 mg20 bar or pressure matched placebo One to 3 minutes after administration of study treatment at the back of the hand or antecubital fosa venipuncture is performed with a needleVacutainer needlesyringe or butterfly at the discretion of the investigator
Subjects 3-18 years are asked to assess pain on venipuncture using Wong-Baker FACES pain rating scale anchored at 0 for no hurt and 5 for hurts worst
Children in the middle 8-12 and older 13-18 age groups will additionally rate pain at the ACF and BOH using a 100 mm VAS anchored at 0 for no pain and at 100 for extreme pain Parentlegal guardian will evaluate childs level of pain on a 100 mm VAS anchored at 0 for no pain and at 100 for extreme pain
Safety ratings of skin are completed immediately prior after at 15 and 30 minutes following the procedure All AEsSAEs will be monitored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None