Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures.
Condition: Pain
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): ALGRX 3268
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Needlestick pain; Venipuncture pain; Procedural pain