Procedural PainPhase 3NCT00140088
Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.
A Phase 3 study testing ALGRX 3268 in people with Procedural Pain, run by AlgoRx Pharmaceuticals at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Procedural Pain
- What is being tested?
- ALGRX 3268
- How many people
- 504 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Apr 2005
- Phase
- Phase 3
- 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 [M/F: 1:1] undergoing venipuncture or peripheral venous cannulation at the antecubital fossa or back of hand. 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.
Who cannot join
- 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).
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: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects.
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.
Read the detailed description
Management of pain 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 to provide within 1-3 minutes painless needle or cathether insertion for blod drawing. ALGRX 3268 is a single-use disposable system, incorporating a drug cassette and glass 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". Assessment of pain will be analyzed in each age group 3-7, 8-12, 13-18 and using Wong-Baker FACES pain rating scale.
Children in the middle (8-12) and older (13-18) age groups will also 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 at 15 and 30 minutes following the procedure. AEs/SAEs will be monitored.
- Conditions
- Procedural Pain
- Being tested
- ALGRX 3268
- Keywords
- Needlestick pain, Venipuncture pain
- Medical subject headings
- 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.
Child's rating of pain on venipuncture following administration of the study treatment.
Secondary outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startDec 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Procedural 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 504 participants
Sponsor and investigators
- Lead sponsor
- AlgoRx Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Zempsky, MD, Principal investigator, Connecticut Childrne's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140088
- Sponsor's protocol ID
- 3268-3-003-1
- Status last verified
- Aug 2005
- First submitted
- 31 Aug 2005
- Last updated
- 1 Sep 2005
- Results posted
- No
Publications
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.
PubMed 26164784Zempsky 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.
PubMed 18450903
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects.
- ClinicalTrials.gov ID
- NCT00140088
- Acronym / sponsor ID
- 3268-3-003-1
- Conditions
- Procedural Pain
- Keywords
- Needlestick pain, Venipuncture pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants
- Lead sponsor
- AlgoRx PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Apr 2005
- First posted
- 1 Sep 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 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
Management of pain 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 to provide within 1-3 minutes painless needle or cathether insertion for blod drawing. ALGRX 3268 is a single-use disposable system, incorporating a drug cassette and glass 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". Assessment of pain will be analyzed in each age group 3-7, 8-12, 13-18 and using Wong-Baker FACES pain rating scale.
Children in the middle (8-12) and older (13-18) age groups will also 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 at 15 and 30 minutes following the procedure. AEs/SAEs will be monitored.
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 (3 listed)
- Outpatient children of either gender [M/F: 1:1] undergoing venipuncture or peripheral venous cannulation at the antecubital fossa or back of hand. 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.
Key exclusion criteria (6 listed)
- 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.
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
Child's rating of pain on venipuncture following administration of the study treatment.
2 secondary outcomes
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.
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 1 Sep 2005.
- Derived from this study: PubMed 26164784Schmitz 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.
- Derived from this study: PubMed 18450903Zempsky 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.
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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 Childrne'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 3 study testing ALGRX 3268 in people with Procedural 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 3 inclusion and 6 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 1 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Child's rating of pain on venipuncture following administration of the study treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140088, which also lists 2 linked publications.
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 1 Sep 2005.