Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:7 - 16
Updated:5/25/2016
Start Date:July 2011
End Date:April 2016

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An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain

The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in
patients of ages 7 to 16 years.

A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive,
who require continuous opioid analgesia for moderate to severe pain.

Inclusion Criteria include:

- Male and female patients, 7 to 16 years of age, inclusive, with malignant and/or
nonmalignant moderate to severe pain requiring or anticipated to require continuous,
around-the-clock, opioid treatment for at least 2 weeks (based on the investigator's
judgment);

- Patients must have written informed consent provided by the parent or legal guardian
and assent provided by the patient, when appropriate;

- Patients on incoming opioids must be taking ≤ 80 mg morphine or equivalent if aged 12
to 16 years or ≤ 40 mg morphine or equivalent if aged 7 to 11 years prior to
initiation with BTDS treatment;

- Patients must be able to understand and complete the age appropriate scale to rate
pain intensity, ie, patients must not have a cognitive developmental delay or any
other condition that would preclude them from completing age appropriate pain scale;

- Patients with malignant and/or nonmalignant medical conditions causing moderate to
severe pain requiring continuous, around-the-clock opioid analgesic therapy such as
cancer, sickle-cell disease (eg, resulting in persistent body pain, persistent limb
pain, avascular necrosis, persistent abdominal pain), persistent orthopedic pain (eg,
spinal injury, spinal disc herniation, persistent limb/stump pain, major trauma),
juvenile rheumatoid arthritis (pain not controlled by therapy treating the underlying
disease), and cystic fibrosis resulting in persistent chest pain;

- Patients must have a parent/caregiver who is willing and able to be compliant with
the protocol, capable of patient evaluation, able to read and understand
questionnaires, willing and able to use a diary, and able to read, understand, and
sign the written informed consent.

Exclusion Criteria include:

- Patients who are allergic to buprenorphine or have a history of allergies to other
opioids (this criterion does not include patients who have experienced common opioid
side effects [eg, nausea, constipation]);

- Patients who have allergies or other contraindications to transdermal delivery
systems or patch adhesives;

- Patients with a dermatological disorder at any relevant patch application site that
would preclude proper placement and/or rotation of BTDS patches;

- Patients with evidence of impaired renal function;

- Patients with hepatic impairment;

- Patients with history of seizures;

- Patients who have a history of sleep apnea within the past year;

- Patients with unstable respiratory disease;

- Patients with structural heart disease or a pacemaker;

- Patients with clinically unstable cardiac disease;

- Patients who, in the opinion of the investigator, are unsuitable to participate in
this study for any reason;

- Patients who receive or anticipate to receive investigational medication/therapy
during study drug treatment period.

Other protocol-specific inclusion/exclusion criteria may apply.
We found this trial at
22
sites
254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
1263
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New Brunswick, NJ
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
1358
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Hartford, CT
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
1169
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Los Angeles, CA
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
974
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Pittsburgh, PA
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803
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
400
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Aurora, CO
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517
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Austin, TX
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Bronx, New York 10467
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Bronx, NY
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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610
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Chicago, IL
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Greenville, North Carolina 27834
1140
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Greenville, NC
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Long Beach, California 90801
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Long Beach, CA
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Los Angeles, California 90095
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656
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Louisville, KY
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1321
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Miami, FL
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New York, NY
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Providence, Rhode Island 02903
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Providence, RI
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San Antonio, Texas 78258
561
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San Antonio, TX
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Shreveport, Louisiana 71118
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Shreveport, LA
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Stony Brook, New York 11794
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Washington, District of Columbia 20060
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Washington,
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976
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Winston-Salem, NC
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