Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Cancer and Breakthrough Pain, sponsored by Cephalon.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00236041 record still lists
NCT00236041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00236041's enrollment target sits among peer trials
38 476th of 615 higher than 135 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
RECRUITING · Phase 2
-
TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
RECRUITING · Phase 2
-
CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth
RECRUITING · Phase 2
-
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
RECRUITING · Phase 2
-
Acupuncture for People Experiencing Period Loss Due to Chemotherapy
RECRUITING · Phase 2
-
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
- NCT04237623 · 38 participants · Phase 2
GM-CSF With Post-Transplant Cyclophosphamide
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia