PainPhase 2NCT00236093
Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
A Phase 2 study testing ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) in people with Pain and Cancer, run by Cephalon at 28 sites in 3 countries.
Trial summary
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) treatment in children with pain associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who are receiving around the clock (ATC) opioid… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Pain, Cancer, Sickle Cell Anemia
- What is being tested?
- ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 28 sitesin 3 countries
- Study dates
- Oct 2006to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children are included in the study if all of the following criteria are met:
- The patient completed participation in ACTIQ double blind study in compliance with the protocol
- Written informed consent of the parent or legal guardian and patient assent, when appropriate, is obtained (lack of assent cannot be overturned)
- The child is aged 3 to under 16 years (at the time of enrollment into the ACTIQ double blind study) and continues to weight at least 15kg
- The child must continue using ATC opioid therapy for pain associated with cancer, sickle cell disease, or severe burns and be opioid-tolerant. Opioid tolerant patients are defined as patients who have taken at least 1 mg/kg/day or 40mg/day or more of oral morphine (or an equianalgesic dosage of another opioid) or at least 25 mcg/hour of transdermal fentanyl for at least 7 days. (ATC opioid therapy may be administered as patient controlled analgesia [PCA]).
- The child must be experiencing episodes of BTP (defined as transient flares of pain that require a bolus of medication as treatment) as follows:
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- Patients with cancer must be experiencing an average of at least 1 BTP episode a day
- Patients with non-cancer related pain must be experiencing an average of 2 BTP episodes a day
- Girls who are postmenarch or sexually active must have a negative urine pregnancy test before entry into the study, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
- The child, in the opinion of the investigator, is able to administer ACTIQ treatment effectively (ie, adequately moving the unit around the mouth and sucking not biting the unit)
- The child may be an inpatient or outpatient
Who cannot join
- Children are excluded from participating in this study if 1 or more of the following criteria are met:
- The child has pain uncontrolled by therapy, as determined by the investigator, that could adversely impact the safety of the patient or could be compromised by treatment with ACTIQ.
- The child has known or suspected hypersensitivities/allergies or other contraindications to any ACTIQ component
- The child has received monoamine oxidase inhibitors (MAOIs) within 14 days of the first dose of study drug administration
- The child has moderate to severe oral mucositis
- The child has a neuromuscular disease, significant renal impairment, or significant hepatic impairment as determined by the investigator
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- The child has any other medical condition or is receiving concomitant medication/therapy that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise data collection
- The child is receiving any experimental drug/therapy. NOTE: Children may not be participating concurrently in another study when the other study requires experimental drug therapy.
- The child is receiving any other treatment that, in the opinion of the investigator, could interfere with the pain response
- A female patient of childbearing potential, is pregnant, or is lactating (any girl becoming pregnant during the study will be withdrawn from the study)
- The child has, in the opinion of the investigator, a development delay that would interfere with the use of ACTIQ therapy
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
United States26 sites
Akron Children's Hospital
Akron, Ohio, 44308
University of New Mexico
Albuquerque, New Mexico, 87131
Duke University Hospital
Durham, North Carolina, 27710
David Center for Childrens Pain and Palliative Care
Hackensack, New Jersey, 07601
Connecticut Childrens Medical
Hartford, Connecticut, 06106
Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Kapi'olani Medical Center
Honolulu, Hawaii, 96826
University Hospitals of Iowa
Iowa City, Iowa, 52242
Nemours Childrens Clinc
Jacksonville, Florida, 32207
Children's Hospital of Arkansas
Little Rock, Arkansas, 72202
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
West Virginia Univeristy
Morgantown, West Virginia, 99204
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Childrens Hospital of Orange
Orange, California, 92868
Lucille Packard Childresns Hospital
Palo Alto, California, 94304
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Children's Cancer and Blood Disorders Center
San Antonio, Texas, 78207
Methodist Hospital
San Antonio, Texas, 78229
Sacred Heart Medical Center
Spokane, Washington, 99204
Scottish Rite Children's Medical Center
Syracuse, New York, 13210
SUNY Upstate Medical University
Syracuse, New York, 13210
St. Joseph's Childrens Hopsital
Tampa, Florida, 33660
Children's Hospital at Montefiore
The Bronx, New York, 10467
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
Tod Childrens Hospital
Youngstown, Ohio, 44501
About this study
Official title: A 4-week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) treatment in children with pain associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who are receiving around the clock (ATC) opioid therapy.
- Conditions
- Pain, Cancer, Sickle Cell Anemia, Severe Burns
- Being tested
- ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])
- Keywords
- Sickle Cell
- Medical subject headings
- Pain, Neoplasms, Anemia, Sickle Cell, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC])Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ treatment in children with pain and BTP who are receiving ATC opioid therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2006
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Messina, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236093
- Sponsor's protocol ID
- C8278/2022/BP/US-CA
- Status last verified
- May 2014
- First submitted
- 7 Oct 2005
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week, Open-Label Extension Study of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) Treatment for Opioid-Tolerant Children and Adolescents With Breakthrough Pain
- ClinicalTrials.gov ID
- NCT00236093
- Acronym / sponsor ID
- C8278/2022/BP/US-CA
- Conditions
- Pain, Cancer, Sickle Cell Anemia, Severe Burns
- Keywords
- Sickle Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) treatment in children with pain associated with cancer, sickle cell disease, or severe burns and breakthrough pain (BTP) who are receiving around the clock (ATC) opioid therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- The patient completed participation in ACTIQ double blind study in compliance with the protocol
- Written informed consent of the parent or legal guardian and patient assent, when appropriate, is obtained (lack of assent cannot be overturned)
- The child is aged 3 to under 16 years (at the time of enrollment into the ACTIQ double blind study) and continues to weight at least 15kg
- The child must continue using ATC opioid therapy for pain associated with cancer, sickle cell disease, or severe burns and be opioid-tolerant. Opioid tolerant patients are defined as patients who have taken at least 1 mg/kg/day or 40mg/day or more of oral morphine (or an equianalgesic dosage of another opioid) or at least 25 mcg/hour of transdermal fentanyl for at least 7 days. (ATC opioid therapy may be administered as patient controlled analgesia [PCA]).
- The child must be experiencing episodes of BTP (defined as transient flares of pain that require a bolus of medication as treatment) as follows:
Key exclusion criteria (11 listed)
- Children are excluded from participating in this study if 1 or more of the following criteria are met:
- The child has pain uncontrolled by therapy, as determined by the investigator, that could adversely impact the safety of the patient or could be compromised by treatment with ACTIQ.
- The child has known or suspected hypersensitivities/allergies or other contraindications to any ACTIQ component
- The child has received monoamine oxidase inhibitors (MAOIs) within 14 days of the first dose of study drug administration
- The child has moderate to severe oral mucositis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) | Drug | – |
Primary outcome
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ treatment in children with pain and BTP who are receiving ATC opioid therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Messina study director
Cephalon
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACTIQ (Oral Transmucosal Fentanyl Citrate [OTFC]) in people with Pain and Cancer, run by Cephalon at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective of the study is to monitor the safety (adverse event data) of longer-term use of ACTIQ treatment in children with pain and BTP who are receiving ATC opioid therapy.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.