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NCT00125255 · ClinicalTrials.gov registry record · Phase 3
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children
A Phase 3 study, sponsored by ZARS Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
NCT00125255 is a Phase 3 study that has completed, run by ZARS Pharma. The registered enrollment target is 81 participants.
The verdict
NCT00125255, a Phase 3 study, has completed, sponsored by ZARS Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
Study Summary
The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects as well as the length of time necessary to provide adequate anesthesia. Recent guidelines strongly advocate for the proactive treatment of pain in children, including the pain associated with medical procedures. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate whether S-Caine Peel is effective in providing topical local dermal anesthesia prior to a vascular access procedure in children 5 through 17 years of age.
Interventions
- DRUG S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
- DRUG Placebo Peel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2005-06 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00125255
The ClinicalTrials.gov registry entry for NCT00125255 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ZARS Pharma, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) is the first listed.
NCT00125255 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00125255 about?
NCT00125255 is a clinical study titled "S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children". The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects as well...
What is the current status of trial NCT00125255?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2005-06. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00125255?
The interventions under investigation include: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) (DRUG), Placebo Peel (DRUG).
Who is sponsoring clinical trial NCT00125255?
This trial is sponsored by ZARS Pharma, which has 23 total clinical trials registered on ClinicalTrials.gov.
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