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Safety of IONSYS in Pediatric Post-Operative Pain
NCT00666393Phase 3
Key facts
- Status
- Withdrawn
- Start
- Oct 2008
- Primary completion
- Dec 2010
- Sponsor
- ALZA Corporation
- Modality
- Orthosteric Ligands
- Drugs
- fentanyl
- Conditions
- postoperative pain
01
Overview
Phase 3, open-label, single-arm trial of fentanyl in postoperative pain, sponsored by ALZA Corporation. Primary endpoints: Adverse Events up to 72 hours, Oxygen Saturation up to 72 hours and 2 more. Planned start Oct 2008; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Experimental Arm
Fentanyl iontophoretic transdermal system (40mcg)
03
Who it enrols
Pediatric patients >= 40 kg scheduled for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery requiring opioid analgesia.
04
Endpoints
Primary
Adverse Events
Oxygen Saturation
Vital Signs
Concomitant Medications
Secondary
Patient Global Assessment
Investigator Global Assessment
Parent Assessment of Patient Use
Serum Fentanyl Concentration
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