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Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)

Primary Purpose

Cancer, Breakthrough Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACTIQ®
Sponsored by
Cephalon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Breakthrough Pain, Cancer, Sickle Cell, Severe Burns, Children, Adolescents, Analgesia, Sickle Cell Disease, Non-Cancer

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 and weighs at least 15 kg. 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]). 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: 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. The child has an average daily pain score of 6 or less (of 10) on the FPS-R. 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. 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). The child must be an inpatient. Exclusion Criteria: 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 before the first ACTIQ treatment. 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. 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 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. A child's exacerbations of pain are only associated with medical procedures (such as radiation therapy, wound dressing, and bone marrow aspiration). The child is receiving any other treatment that, in the opinion of the investigator, could interfere with the pain response. 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.) The child has, in the opinion of the investigator, developmental delay that would interfere with the use of ACTIQ therapy.

Sites / Locations

  • Children's Hospital of Arkansas
  • UCLA Pediatric Pain Program
  • Childrens Hospital of Orange
  • Lucille Packard Childrens Hospital
  • Connecticut Childrens Medical Center
  • Children's National Medical Center
  • Nemours Childrens Clinic
  • St. Joseph's Children's Hospital
  • Scottish Rite Children's Medical Center
  • Kapi'olani Medical Center
  • Children's Memorial Center
  • Children's Memorial Hospital
  • University Hospitals of Iowa
  • Cardinal Glennon Children's Hospital
  • Hackensack University Medical Center
  • Cancer Institute of New Jersey
  • University of New Mexico
  • Children's Hospital at Montefiore
  • SUNY Upstate Medical University
  • Duke University Hospital
  • Akron Children's Hospital
  • Tod Children's Hospital
  • Milton S Hershey Medical Center
  • St. Christopher's Hospital for Children
  • Vanderbilt University Medical
  • Children's Cancer and Blood Disorders Center
  • Methodist Hospital
  • Sacred Heart Medical Center
  • West Virginia University
  • Childrens Hospital of Wisconsin
  • San Jorge Childrens Medical

Outcomes

Primary Outcome Measures

Pain intensity differences as measured by the FPS-R

Secondary Outcome Measures

Time to adequate analgesia
Duration of analgesia
Percentage of BTP episodes requiring rescue medication, or for which oversedation occurs
Amount of rescue medication
Distribution of optimal doses

Full Information

First Posted
October 7, 2005
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00236041
Brief Title
Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breakthrough Pain
Keywords
Breakthrough Pain, Cancer, Sickle Cell, Severe Burns, Children, Adolescents, Analgesia, Sickle Cell Disease, Non-Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
38 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ACTIQ®
Primary Outcome Measure Information:
Title
Pain intensity differences as measured by the FPS-R
Secondary Outcome Measure Information:
Title
Time to adequate analgesia
Title
Duration of analgesia
Title
Percentage of BTP episodes requiring rescue medication, or for which oversedation occurs
Title
Amount of rescue medication
Title
Distribution of optimal doses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 and weighs at least 15 kg. 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]). 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: 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. The child has an average daily pain score of 6 or less (of 10) on the FPS-R. 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. 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). The child must be an inpatient. Exclusion Criteria: 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 before the first ACTIQ treatment. 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. 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 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. A child's exacerbations of pain are only associated with medical procedures (such as radiation therapy, wound dressing, and bone marrow aspiration). The child is receiving any other treatment that, in the opinion of the investigator, could interfere with the pain response. 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.) The child has, in the opinion of the investigator, developmental delay that would interfere with the use of ACTIQ therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Messina, Pharm D
Organizational Affiliation
Cephalon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UCLA Pediatric Pain Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Childrens Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucille Packard Childrens Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Connecticut Childrens Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Nemours Childrens Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
St. Joseph's Children's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Scottish Rite Children's Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Kapi'olani Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Children's Memorial Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
University Hospitals of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Tod Children's Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Vanderbilt University Medical
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Children's Cancer and Blood Disorders Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
99204
Country
United States
Facility Name
Childrens Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Facility Name
San Jorge Childrens Medical
City
San Juan
ZIP/Postal Code
00912
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)

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