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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00236041 |
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.
Condition | Intervention | Phase |
---|---|---|
Cancer Breakthrough Pain |
Drug: ACTIQ® |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 38 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | August 2006 |
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:
Ages Eligible for Study: | 3 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The child must be experiencing episodes of BTP (defined as a transient flare of pain that requires a bolus of medication as treatment) as follows:
Exclusion Criteria:
Study Director: | John Messina, Pharm D | Cephalon |
Study ID Numbers: | C8278b/202/BP/US-CA |
Study First Received: | October 7, 2005 |
Last Updated: | May 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00236041 |
Health Authority: | United States: Food and Drug Administration |
Breakthrough Pain Cancer Sickle Cell Severe Burns Children |
Adolescents Analgesia Sickle Cell Disease Non-Cancer |
Burns Fentanyl Citric Acid |
Pain Anemia, Sickle Cell Sickle cell anemia |