PainPhase 2NCT00132405
Study of ALGRX 3268 for Needlestick Pain in Children
A Phase 2 study testing ALGRX 3268 in people with Pain, run by AlgoRx Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- ALGRX 3268
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Outpatient children of either gender who were to undergo venipuncture at the back of the hand
- Children must have had 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 mm VAS (ages 8-18).
- Ages 3 to 7 years; 8 to 12 years; and 13 to 18 years, inclusive
- Consent forms must have been approved by the appropriate Institutional Review Board (IRB). Signed informed consent must have been granted by the parent or legal guardian and assent to participate should have been sought (either verbally or in writing) from each child.
- In females of childbearing potential, who in the judgment of the investigator or designee were sexually active, a negative urine pregnancy test must have been documented prior to enrollment. A negative urine pregnancy test was required in all teenage girls over the age of 14 years. Surgically sterile females did not require a pregnancy test.
Who cannot join
- Previous history of allergic reactions to any local anesthetic
- Any medical condition or instability that, in the judgment 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 tattoos, 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 who planned to become pregnant; 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 two weeks (longer if bruising was apparent)
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: 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
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.
Read the detailed description
ALGRX 3268 (previously known as PowderJect® Dermal Lidocaine) is a system for needle-free, pain-free epidermal injection of lidocaine powder that provides local anesthesia within 3 minutes to provide painless needle or catheter insertion for blood drawing. ALGRX 3268 is a single use disposable system, incorporating a drug cassette and gas cylinder into a single hand held device, with a button to actuate the system. This is a single center, randomized, double-blind, placebo (sham) controlled, single dose, parallel group study in pediatric subjects scheduled to undergo venipuncture. Three age groups are enrolled: 3-7 years, 8-12 years, and 13-18 years. Within each age group, subjects are randomized to receive ALGRX 3268 0.5 mg/20 bar or pressure matched placebo. Two to 3 minutes after administration of study treatment at the back of the hand, venipuncture is performed with either a needle/Vacutainer®, needle/syringe or "butterfly," at the discretion of the investigator. Subjects aged 3-7 are asked to rate the pain of venipuncture using the Wong-Baker FACES Pain Rating Scale, anchored at 0 for "no hurt" and 5 for "hurts worst." Subjects in oldest age group complete a 100 mm visual analogue scale (VAS), anchored at 0 for "no pain" and at 100 for "extreme pain." Subjects in the middle group used both the Wong-Baker FACES scale and the VAS to rate the pain of venipuncture. Safety ratings of skin are completed 15, 30, and 60 minutes after the procedure.
- Conditions
- Pain
- Being tested
- ALGRX 3268
- Keywords
- Needlestick pain, Venipuncture pain, Procedural pain
- Medical subject headings
- Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALGRX 3268Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's assessment of the pain of venipuncture following administration of study treatment
Secondary outcomes (1)
Parents are asked to assess their child's level of pain of venipuncture on a 100 mm visual analogue scale (VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startMay 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 260 participants
Sponsor and investigators
- Lead sponsor
- AlgoRx Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Zempsky, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132405
- Sponsor's protocol ID
- 3268-2-002-1
- Status last verified
- Aug 2005
- First submitted
- 15 Aug 2005
- Last updated
- 10 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00132405
- Acronym / sponsor ID
- 3268-2-002-1
- Conditions
- Pain
- Keywords
- Needlestick pain, Venipuncture pain, Procedural pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants
- Lead sponsor
- AlgoRx PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Sep 2004
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ALGRX 3268 (previously known as PowderJect® Dermal Lidocaine) is a system for needle-free, pain-free epidermal injection of lidocaine powder that provides local anesthesia within 3 minutes to provide painless needle or catheter insertion for blood drawing. ALGRX 3268 is a single use disposable system, incorporating a drug cassette and gas cylinder into a single hand held device, with a button to actuate the system. This is a single center, randomized, double-blind, placebo (sham) controlled, single dose, parallel group study in pediatric subjects scheduled to undergo venipuncture. Three age groups are enrolled: 3-7 years, 8-12 years, and 13-18 years. Within each age group, subjects are randomized to receive ALGRX 3268 0.5 mg/20 bar or pressure matched placebo. Two to 3 minutes after administration of study treatment at the back of the hand, venipuncture is performed with either a needle/Vacutainer®, needle/syringe or "butterfly," at the discretion of the investigator. Subjects aged 3-7 are asked to rate the pain of venipuncture using the Wong-Baker FACES Pain Rating Scale, anchored at 0 for "no hurt" and 5 for "hurts worst." Subjects in oldest age group complete a 100 mm visual analogue scale (VAS), anchored at 0 for "no pain" and at 100 for "extreme pain." Subjects in the middle group used both the Wong-Baker FACES scale and the VAS to rate the pain of venipuncture. Safety ratings of skin are completed 15, 30, and 60 minutes after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Outpatient children of either gender who were to undergo venipuncture at the back of the hand
- Children must have had 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 mm VAS (ages 8-18).
- Ages 3 to 7 years; 8 to 12 years; and 13 to 18 years, inclusive
- Consent forms must have been approved by the appropriate Institutional Review Board (IRB). Signed informed consent must have been granted by the parent or legal guardian and assent to participate should have been sought (either verbally or in writing) from each child.
- In females of childbearing potential, who in the judgment of the investigator or designee were sexually active, a negative urine pregnancy test must have been documented prior to enrollment. A negative urine pregnancy test was required in all teenage girls over the age of 14 years. Surgically sterile females did not require a pregnancy test.
Key exclusion criteria (8 listed)
- Previous history of allergic reactions to any local anesthetic
- Any medical condition or instability that, in the judgment 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 tattoos, surgical scars, ports, implantable devices or a skin condition that may have interfered with placement of study treatment or skin site assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALGRX 3268 | Drug | – |
Primary outcome
Subject's assessment of the pain of venipuncture following administration of study treatment
1 secondary outcome
Parents are asked to assess their child's level of pain of venipuncture on a 100 mm visual analogue scale (VAS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Zempsky, MD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALGRX 3268 in people with Pain, run by AlgoRx Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's assessment of the pain of venipuncture following administration of study treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2005.