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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


Phase 2
3 Years
15 Years
Not Enrolling
Both
Cancer, Breakthrough Pain

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Pain intensity differences as measured by the FPS-R

Principal Investigator

John Messina, Pharm D

Investigator Role:

Study Director

Investigator Affiliation:

Cephalon

Authority:

United States: Food and Drug Administration

Study ID:

C8278b/202/BP/US-CA

NCT ID:

NCT00236041

Start Date:

April 2004

Completion Date:

August 2006

Related Keywords:

  • Cancer
  • Breakthrough Pain
  • Breakthrough Pain
  • Cancer
  • Sickle Cell
  • Severe Burns
  • Children
  • Adolescents
  • Analgesia
  • Sickle Cell Disease
  • Non-Cancer

Name

Location

Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's National Medical Center Washington, District of Columbia  20010-2970
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Akron Children's Hospital Akron, Ohio  44308-1062
Tod Children's Hospital Youngstown, Ohio  44501
St. Joseph's Children's Hospital Tampa, Florida  33677-4227
Methodist Hospital Houston, Texas  77030
SUNY Upstate Medical University Syracuse, New York  13210
Children's Memorial Hospital Chicago, Illinois  60614
University of New Mexico Albuquerque, New Mexico  87131
Sacred Heart Medical Center Spokane, Washington  99204
West Virginia University Morgantown, West Virginia  26506
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
Nemours Childrens Clinic Jacksonville, Florida  32207
Scottish Rite Children's Medical Center Atlanta, Georgia  30342
Kapi'olani Medical Center Honolulu, Hawaii  96826
Children's Memorial Center Chicago, Illinois  60614
University Hospitals of Iowa Iowa City, Iowa  52242
Children's Hospital at Montefiore Bronx, New York  10467
Duke University Hospital Durham, North Carolina  27710
Milton S Hershey Medical Center Hershey, Pennsylvania  17033
Vanderbilt University Medical Nashville, Tennessee  37232
Children's Cancer and Blood Disorders Center San Antonio, Texas  78207
Childrens Hospital of Wisconsin Milwaukee, Wisconsin  53201