NCT00236093

Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain

A 4-week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ (Oral Transmucosal Fentanyl Citrate \[OTFC\]) treatment in children with pain associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who are receiving around the clock (ATC) opioid therapy.

Conditions

• Pain
• Cancer
• Sickle Cell Anemia
• Severe Burns

Interventions

Type	Name	Description
DRUG	ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-12-01
• First posted: 2005-10-12
• Last updated: 2014-05-09

Locations

28 sites across 3 countries: United States, Canada, Puerto Rico