A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy

2014-08-27 03:46:57 | BioPortfolio


The objective of this study is to assess the safety of treatment with Duragesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50, 75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy. Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the subject's current narcotic pain relief therapy, and to the parameters for increasing the Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.


This is a single-arm, nonrandomized, open-label, multicenter trial designed to enroll a total of approximately 200 pediatric subjects with moderate to severe chronic pain due to malignant or nonmalignant disease. Subjects must have received opioids continuously for a minimum of 7 days prior to enrollment with a projected need for continuous opioids for at least the length of the primary treatment period. Subjects must also have received the equivalent of at least 30 mg of oral morphine on the day prior to enrollment. Subjects were enrolled into 3 age cohorts including 2 to <6 years, 6 to <12 years, and 12 to <16 years. The study consisted of a 15-day primary treatment period. After the 15-day primary treatment period, subjects may, at the investigator's discretion, continue long-term treatment with Duragesic® as long as medically appropriate. The objective of this study is to provide an evaluation of the safety of Duragesic® in pediatric subjects who require treatment with a potent opioid for the management of chronic pain. On Day 1, subjects are converted from oral or parenteral opioids to Duragesic® by calculating the previous 24-hour opioid analgesic requirement. This amount is then converted to the equi-analgesic oral morphine dose, and then used to determine the corresponding Duragesic® dose. Short-acting oral or parenteral opioids are used as rescue medication at any time during the study to treat breakthrough pain (pain not adequately controlled by Duragesic®). Following initiation of Duragesic® treatment using the recommended dose, subjects are titrated upwards (no more frequently than every 3 days after the initial dose) until analgesic effectiveness is attained. Titration is based on supplemental opioid consumption, such that the dose of Duragesic® is increased by 12.5 micrograms/hour for every 45 mg of oral morphine consumed on the 2nd or 3rd days following the last patch change, up to a maximum increase of 25 micrograms/hour at any one time. The primary endpoint of this trial is the determination of the safety profile of Duragesic® in the defined target population. Safety is assessed by monitoring adverse events, vital sign measurements, and through physical examination. In addition, respiratory rate and level of sedation are closely monitored during the first 72 hours. The assessment of clinical utility includes the parent's global assessment of pain control on Days 1 and 16, the pain level assessed by the parent and the patient twice daily, once in the morning and in the evening (or assessed by the parent only if the patient is younger than age 6), the pain level at the time rescue medication is given and one hour afterwards, the child's play performance, and a quality-of-life child health questionnaire (CHQ) used to measure the physical, psychosocial functioning and well being of children 5 years of age. During the primary treatment period, serum fentanyl concentrations are also measured. Sparse pharmacokinetic sampling is incorporated into the trial design to facilitate population pharmacokinetic analysis.

Study Design

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


Chronic Pain


Duragesic® (fentanyl) Therapeutic Transdermal System (TTS)




Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:46:57-0400

Clinical Trials [3416 Associated Clinical Trials listed on BioPortfolio]

A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy

The objective of this study is to assess the safety and clinical utility of Duragesic® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the t...

Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System

The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Myl...

Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr

The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. ...

A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System

To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.

Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatme...

PubMed Articles [22933 Associated PubMed Articles listed on BioPortfolio]

Human Factors Results for Fentanyl Iontophoretic Transdermal System (ITS) With Enhanced Controller for Postoperative Pain Management.

The purpose of this analysis was to conduct summative usability evaluations, including behavioral and subjective evaluations, for the fentanyl iontophoretic transdermal system (ITS).

Transdermal Fentanyl Solution Provides Long-term Analgesia in the Hind-paw Incisional Model of Postoperative Pain in Male Rats.

A recently developed transdermal fentanyl solution was hypothesized to be effective for non-invasive postoperative analgesia in rats.

Unusual case of transdermal fentanyl in cachexia.

Fentanyl has a low molecular weight and is lipophilic making it suitable for transdermal administration. However, multiple factors appear to lead to interindividual variation in absorption via this ro...

Abuse of fentanyl: An emerging problem to face.

Fentanyl is a potent synthetic opioid used as a narcotic analgesic supplement in general and regional anesthesia as well as in management of persistent, severe chronic pain. Alarming epidemiological a...

The IASP classification of chronic pain for ICD-11: applicability in primary care.

The International Classification of Diseases, 11th Revision (ICD-11), proposes, for the first time, a coding system for chronic pain. This system contains 1 code for "chronic primary pain," where chro...

Medical and Biotech [MESH] Definitions

Facilities providing diagnostic, therapeutic, and palliative services for patients with severe chronic pain. These may be free-standing clinics or hospital-based and serve ambulatory or inpatient populations. The approach is usually multidisciplinary. These clinics are often referred to as "acute pain services". (From Br Med Bull 1991 Jul;47(3):762-85)

A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)

Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions.

Aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain.

Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions.

More From BioPortfolio on "A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy"

Quick Search


Relevant Topics

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Searches Linking to this Trial