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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

Phase 3
7 Years
16 Years
Open (Enrolling)

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Trial Information

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

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

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of participants with adverse events as a measure of safety.

Outcome Time Frame:

4 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

August 2014

Related Keywords:

  • Pain
  • Pain
  • Opioid
  • Analgesia
  • Moderate to severe pain



Hurley Medical Center Flint, Michigan  48503
Cardinal Glennon Children's Medical Center St. Louis, Missouri  63104
Lucile Packard Children's Hospital Redwood City, California  94063-5334
Children's Center for Cancer and Blood Diseases Indianapolis, Indiana  46260
Kosair Charities Pediatric Clinical Research Unit - University of Louisville Louisville, Kentucky  40202
Discovery Clinical Trials Marrero, Louisiana  70072
Willis-Knighton Physician Network Shreveport, Louisiana  71118
Massachusetts General Hospital - Center for Pain Medicine Boston, Massachusetts  02114
The University of North Carolina - Department of Anesthesiology Chapel Hill, North Carolina  27599
The Center for Clinical Research - Carolina Pain Institute Winston-Salem, North Carolina  27103
Road Runner Research, Ltd. San Antonio, Texas  78258