Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
Public ClinicalTrials.gov record NCT00236041. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00236041
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 15 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2004 (Type not available)
- Primary completion
- Not listed
- Completion
- Aug 2006 (Type not available)
- Last update posted
- May 9, 2014
2004 – 2006
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Arkansas | Little Rock | Arkansas | 72202 | — |
| UCLA Pediatric Pain Program | Los Angeles | California | 90095 | — |
| Childrens Hospital of Orange | Orange | California | 92868 | — |
| Lucille Packard Childrens Hospital | Palo Alto | California | 94304 | — |
| Connecticut Childrens Medical Center | Hartford | Connecticut | 06106 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Nemours Childrens Clinic | Jacksonville | Florida | 32207 | — |
| St. Joseph's Children's Hospital | Tampa | Florida | 33607 | — |
| Scottish Rite Children's Medical Center | Atlanta | Georgia | 30342 | — |
| Kapi'olani Medical Center | Honolulu | Hawaii | 96826 | — |
| Children's Memorial Center | Chicago | Illinois | 60614 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| University Hospitals of Iowa | Iowa City | Iowa | 52242 | — |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Duke University Hospital | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Tod Children's Hospital | Youngstown | Ohio | 44501 | — |
| Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| Vanderbilt University Medical | Nashville | Tennessee | 37232 | — |
| Children's Cancer and Blood Disorders Center | San Antonio | Texas | 78207 | — |
| Methodist Hospital | San Antonio | Texas | 78229 | — |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
| West Virginia University | Morgantown | West Virginia | 99204 | — |
| Childrens Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00236041, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2014 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00236041 live on ClinicalTrials.gov.