Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
Information source: Cephalon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Breakthrough Pain
Intervention: ACTIQ® (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Cephalon Official(s) and/or principal investigator(s):
John Messina, Pharm D, Study Director, Affiliation: Cephalon
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Pain intensity differences as measured by the FPS-R
Secondary outcome: Time to adequate analgesiaDuration of analgesia Percentage of BTP episodes requiring rescue medication, or for which oversedation occurs Amount of rescue medication Distribution of optimal doses
Detailed description:
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 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.
The secondary objectives are:
- to evaluate the characteristics of BTP in children with pain, including their response
to treatment
- to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these
children with regard to time to adequate analgesia by utilizing a stop watch to measure
the time for each unit of study drug in the double blind phase
- to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these
children by assessing the occurrence of inadequate analgesia as assessed by the use of
rescue medication
- to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these
children by assessing the numbers of patients who withdraw from the study because of
inadequate analgesia
- to evaluate the efficacy of ACTIQ treatment compared to placebo treatment for these
children by assessing the duration of analgesic effect by using the FPS–R administered
at approximately 30, 45, and 60 minutes after the start of each unit of study drug after
an optimal dosage is obtained
- to determine the distribution of optimal doses of ACTIQ treatment for these children by
age group (3 to under 6 years, 6 to under 11 years, and 11 to under 16 years)
- to establish a safe and effective titration scheme for ACTIQ in these children during
the open label phase
- to evaluate the safety of ACTIQ treatment for these children through the assessment of
adverse events, clinical laboratory assessments (serum chemistry and hematology), vital
sign measurements (including blood pressure, heart rate, and respiration rate),
hemoglobin-oxygen saturation level (SpO2, measured via pulse oximetry),
electrocardiograms (ECGs), physical examinations, and level of sedation (measured by the
University of Michigan Sedation Scale [UMSS])
- to characterize the pharmacokinetics profile of ACTIQ (fentanyl citrate) in these
children
- to investigate the exposure and efficacy relationship between plasma concentration of
fentanyl and clinical measures of analgesia
Eligibility
Minimum age: 3 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Written informed consent of the parent or legal guardian and patient assent, when
appropriate, is obtained. (Lack of assent cannot be overturned.)
2. The child is aged 3 to under 16 years and weighs at least 15 kg.
3. The child must be using ATC opioid therapy for pain associated with cancer and be
opioid-tolerant. NOTE: This requirement is defined as the patient receiving at least 1
mg/kg/day or 40 mg/day or more of oral morphine (or an equi-analgesic 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]).
4. The child must be experiencing episodes of BTP (defined as a transient flare of pain
that requires a bolus of medication as treatment) as follows:
1. patients with cancer must be experiencing an average of at least 1 BTP episode a
day.
2. patients with non-cancer related pain must be experiencing an average of 2 BTP
episodes a day.
5. The child has an average daily pain score of 6 or less (of 10) on the FPS-R.
6. Girls who are postmenarche or sexually active must have a negative urine pregnancy
test prior to the baseline visit, 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.
7. The child, in the opinion of the investigator, is able to administer ACTIQ treatment
effectively (ie, adequately moving the unit around in the mouth and sucking, not
biting, the unit).
8. The child must be an inpatient.
Exclusion Criteria:
1. 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.
2. The child has known or suspected hypersensitivities/allergies or other
contraindications to any ACTIQ component.
3. The child has received monoamine oxidase inhibitors (MAOIs) within 14 days before the
first ACTIQ treatment.
4. The child has moderate to severe oral mucositis.
5. The child has a neuromuscular disease, significant renal impairment, or significant
hepatic impairment as determined by the investigator.
6. 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.
7. The child has received any experimental drug/therapy within 14 days of the first ACTIQ
treatment. NOTE: Children may not be participating concurrently in another study when
the other study requires experimental drug therapy.
8. A child's exacerbations of pain are only associated with medical procedures (such as
radiation therapy, wound dressing, and bone marrow aspiration).
9. The child is receiving any other treatment that, in the opinion of the investigator,
could interfere with the pain response.
10. For a female patient of childbearing potential: is pregnant or lactating. (Any female
patient becoming pregnant during the study will be withdrawn from the study.)
11. The child has, in the opinion of the investigator, developmental delay that would
interfere with the use of ACTIQ therapy.
Locations and Contacts
San Jorge Childrens Medical, San Juan 00912, Puerto Rico
Children's Hospital of Arkansas, Little Rock, Arkansas 72202, United States
Lucille Packard Childrens Hospital, Palo Alto, California 94304, United States
Childrens Hospital of Orange, Orange, California 92868, United States
UCLA Pediatric Pain Program, Los Angeles, California 90095, United States
Connecticut Childrens Medical Center, Hartford, Connecticut 06106, United States
Children's National Medical Center, Washington, District of Columbia 20010, United States
Nemours Childrens Clinic, Jacksonville, Florida 32207, United States
St. Joseph's Children's Hospital, Tampa, Florida 33607, United States
Scottish Rite Children's Medical Center, Atlanta, Georgia 30342, United States
Kapi'olani Medical Center, Honolulu, Hawaii 96826, United States
Children's Memorial Center, Chicago, Illinois 60614, United States
Children's Memorial Hospital, Chicago, Illinois 60614, United States
University Hospitals of Iowa, Iowa City, Iowa 52242, United States
Cardinal Glennon Children's Hospital, St. Louis, Missouri 63104, United States
Hackensack University Medical Center, Hackensack, New Jersey 07601, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States
University of New Mexico, Albuquerque, New Mexico 87131, United States
Children's Hospital at Montefiore, Bronx, New York 10467, United States
SUNY Upstate Medical University, Syracuse, New York 13210, United States
Duke University Hospital, Durham, North Carolina 27710, United States
Tod Children's Hospital, Youngstown, Ohio 44501, United States
Akron Children's Hospital, Akron, Ohio 44308, United States
Milton S Hershey Medical Center, Hershey, Pennsylvania 17033, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States
Vanderbilt University Medical, Nashville, Tennessee 37232, United States
Methodist Hospital, San Antonio, Texas 78229, United States
Children's Cancer and Blood Disorders Center, San Antonio, Texas 78207, United States
Sacred Heart Medical Center, Spokane, Washington 99204, United States
West Virginia University, Morgantown, West Virginia 99204, United States
Childrens Hospital of Wisconsin, Milwaukee, Wisconsin 53201, United States
Additional Information
Starting date: April 2004
Ending date: August 2006
Last updated: May 25, 2007
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