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Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
NCT00236041 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00236041 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00236041?
The interventions under investigation include: ACTIQ® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00236041?
This trial is sponsored by Cephalon, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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