Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236041
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-10-07
Brief Title:
EfficacySafety Study of ACTIQ for Opioid-Tolerant Children and Adolescents With Breakthrough Pain BTP
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Double-Blind Placebo-Comparison Study to Evaluate the Efficacy and Safety of ACTIQ Oral Transmucosal Fentanyl Citrate OTFC Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain BTP compared to placebo treatment in children with cancer and non-cancer pain who are receiving around-the-clock ATC opioid therapy and who require additional therapy for BTP episodes This will be determined by the analysis of the pain intensity PI measured by the Faces Pain Scale-Revised FPS-R administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage
Detailed Description:
The primary objective of the study is to evaluate the efficacy of ACTIQ treatment for the management of breakthrough pain BTP compared to placebo treatment in children with pain who are receiving around-the-clock ATC opioid therapy and who require additional therapy for BTP episodes This will be determined by the analysis of the pain intensity PI measured by the Faces Pain Scale-Revised FPS-R administered 15 minutes after the start of each unit of study drug with an optimal ACTIQ dosage
The secondary objectives are
to evaluate the characteristics of BTP in children with pain including their response to treatment
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children with regard to time to adequate analgesia by utilizing a stop watch to measure the time for each unit of study drug in the double blind phase
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the occurrence of inadequate analgesia as assessed by the use of rescue medication
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the numbers of patients who withdraw from the study because of inadequate analgesia
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the duration of analgesic effect by using the FPS-R administered at approximately 30 45 and 60 minutes after the start of each unit of study drug after an optimal dosage is obtained
to determine the distribution of optimal doses of ACTIQ treatment for these children by age group 3 to under 6 years 6 to under 11 years and 11 to under 16 years
to establish a safe and effective titration scheme for ACTIQ in these children during the open label phase
to evaluate the safety of ACTIQ treatment for these children through the assessment of adverse events clinical laboratory assessments serum chemistry and hematology vital sign measurements including blood pressure heart rate and respiration rate hemoglobin-oxygen saturation level SpO2 measured via pulse oximetry electrocardiograms ECGs physical examinations and level of sedation measured by the University of Michigan Sedation Scale UMSS
to characterize the pharmacokinetics profile of ACTIQ fentanyl citrate in these children
to investigate the exposure and efficacy relationship between plasma concentration of fentanyl and clinical measures of analgesia
The secondary objectives are
to evaluate the characteristics of BTP in children with pain including their response to treatment
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children with regard to time to adequate analgesia by utilizing a stop watch to measure the time for each unit of study drug in the double blind phase
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the occurrence of inadequate analgesia as assessed by the use of rescue medication
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the numbers of patients who withdraw from the study because of inadequate analgesia
to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these children by assessing the duration of analgesic effect by using the FPS-R administered at approximately 30 45 and 60 minutes after the start of each unit of study drug after an optimal dosage is obtained
to determine the distribution of optimal doses of ACTIQ treatment for these children by age group 3 to under 6 years 6 to under 11 years and 11 to under 16 years
to establish a safe and effective titration scheme for ACTIQ in these children during the open label phase
to evaluate the safety of ACTIQ treatment for these children through the assessment of adverse events clinical laboratory assessments serum chemistry and hematology vital sign measurements including blood pressure heart rate and respiration rate hemoglobin-oxygen saturation level SpO2 measured via pulse oximetry electrocardiograms ECGs physical examinations and level of sedation measured by the University of Michigan Sedation Scale UMSS
to characterize the pharmacokinetics profile of ACTIQ fentanyl citrate in these children
to investigate the exposure and efficacy relationship between plasma concentration of fentanyl and clinical measures of analgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None