Program Cancelled.
An Open-Label Evaluation of Safety of the IONSYS System [Fentanyl Iontophoretic Transdermal System (40ug) for Management of Acute Post-Operative Pain in Pediatric Patients
Sponsor study identifier
Secondary identifiers
OTHER · Alza Corporation, DE, USA
interventional
0
0 countries
N/A
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 22, 2008
Actual (reported)April 24, 2008
Actual (reported)October 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter.
Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours.
Patient Global Assessment, Investigator Global Assessment and Parent Assessment of Patient Use will be completed every 24 hours. Serum fentanyl concentration will be collected at Hours 3, 6,12, and 24.
Patient, Investigator and Parent Assessments of the treatment will be completed every 24 hours for a maximum of 72 hours. Pharmacokinetic measurements will be completed 4 times during every 24 hours of treatment for a maximum of 12 times over 72 hours.
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
Alza Corporation Clinical Trial
ALZA
0 participants (actual enrollment reported by the registry).
First Submitted
April 22, 2008
First Posted
April 24, 2008
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 3, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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