Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures.

NCT ID: NCT00146185

Last Updated: 2005-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2005-07-31

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 PowderJect(R) 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 0.5 mg/20 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 needle/Vacutainer, needle/syringe 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". Parent/legal guardian will evaluate child's 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 AEs/SAEs will be monitored.

Conditions

Pain

Keywords

Needlestick pain; Venipuncture pain; Procedural pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ALGRX 3268

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Outpatient children of either gender [M/F: 1:1] undergoing venipuncture or peripheral venous cannulation at the ATF or BOH. Children must have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES Pain Rating Scale, (ages 3-12) and/or the extremes of pain on a 100 VAS (ages 8-18).
• Ages 3-7, 8-12, 13-18 years inclusive. Informed consent forms must have been approved by the appropriate IRB. Signed informed consent must have been granted by the parent/legal guardian and assent to participate should have been sought (either verbally or in writting) from each child.
• In females of childbearing potential who in the judgement of the investigator or designee were sexually active, a negative preganancy test must have been documented prior to enrollment. A negative urine preganancy test was required in all teenage girls over the age of 14 years. Surgically sterile females do not require a pregnancy test.

Exclusion Criteria

• Previous history of allergic reactions to any local anesthetic. Any medical condition or instability that in the judgement of the investigator might have adversely impacted the conduct of the study and the collection of data.
• Subjects in whom the investigator determined that venipuncture could not be accomplished cleanly.
• Active local infection or other skin pathology on the dorsum of the hand. Subjects with tattos, surgical scars, ports, implantable devices or a skin condition that may have interfered with placement of study treatment or skin site assessments.
• Female subjects who were pregnant or lactating; females with a positive serum or urine pregnancy test; females of childbearing potential who were not using adequate contraception.
• Prior participation in an ALGRX 3268 study.
• Venipuncture at the proposed site within the prior 2 weeks (longer if bruising was apparent).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AlgoRx Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Eliot Krane, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Stanford, CA

Locations

Department of Anesthesia

Stanford, California, United States

Countries

United States

Other Identifiers

3268-3-004-1

Identifier Type: -

Identifier Source: org_study_id