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NCT00236041 · ClinicalTrials.gov registry record · Phase 2
Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
A Phase 2 study of Cancer and Breakthrough Pain, sponsored by Cephalon.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 20
- Study locations
NCT00236041 is a Phase 2 study of Cancer and Breakthrough Pain that has completed, run by Cephalon. The registered enrollment target is 38 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT00236041, a Phase 2 study of Cancer and Breakthrough Pain, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG ACTIQ®
Study Locations (20)
California
- UCLA Pediatric Pain Program - Los Angeles
- Childrens Hospital of Orange - Orange
- Lucille Packard Childrens Hospital - Palo Alto
Florida
- Nemours Childrens Clinic - Jacksonville
- St. Joseph's Children's Hospital - Tampa
Illinois
- Children's Memorial Center - Chicago
- Children's Memorial Hospital - Chicago
New Jersey
- Hackensack University Medical Center - Hackensack
- Cancer Institute of New Jersey - New Brunswick
New York
- SUNY Upstate Medical University - Syracuse
- Children's Hospital at Montefiore - The Bronx
Arkansas
- Children's Hospital of Arkansas - Little Rock
Connecticut
- Connecticut Childrens Medical Center - Hartford
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-04 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00236041
The ClinicalTrials.gov registry entry for NCT00236041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which ACTIQ® is the first listed.
NCT00236041 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00236041 about?
NCT00236041 is a clinical study titled "Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)". 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...
What is the current status of trial NCT00236041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2004-04. Estimated completion is 2006-08.
What conditions does trial NCT00236041 study?
This clinical trial studies the following conditions: Cancer, Breakthrough Pain.
What interventions are being tested in trial NCT00236041?
The interventions under investigation include: ACTIQ® (DRUG).
Who is sponsoring clinical trial NCT00236041?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00236041 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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