Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics - - Full Text View

Sponsor:	Janssen Pharmaceutical K.K.
Information provided by:	Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:	NCT00216658

Purpose

The purpose of this study is to verify the effectiveness, safety and pharmacokinetics of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, or 50 mcg/hr in Japanese patients with cancer pain who have been switched from minimum amount of existing morphine preparations, such as equivalent to less than 45 mg/day of oral morphine, or oral oxycodone preparations equivalent to less than 30 mg/day.

Condition	Intervention	Phase
Pain, Intractable	Drug: fentanyl	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open Label Study to Confirm Effectiveness, Safety and Pharmacokinetics of Fentanyl Transdermal Matrix Patch, in Japanese Patients With Cancer Pain Who Have Had a Minimum Amount of Morphine Therapy, Such as Equal to Less Than 45 mg/Day of Oral Morphine or Oxycodone Equal to Less Than 30 mg/Day.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:

Patient's global assessments of pain

Secondary Outcome Measures:

Physician's global assessments, pain intensity (Visual Analog Scale: VAS), pain intensity (categorical scale), total pain duration per day, and dose of rescue medication, Adverse events, laboratory values, and vital signs. Pharmacokinetics

Estimated Enrollment:	85
Study Start Date:	December 2004
Estimated Study Completion Date:	September 2005

Detailed Description:

Fentanyl transdermal matrix patch is a narcotic analgesic agent. Compared with the existing reservoir-type Durotep® Patch, it is not liable to leakage of drug solution and does not contain alcohol, which becomes a cause of skin irritation. Also this new formulation becomes available of smaller one of 12.5 mcg/hr while the smallest Durotep® Patch is 25 mcg/hr. This clinical trial was planned to assess effectiveness, safety and pharmacokinetics of fentanyl transdermal matrix patch at an initial transdermal dose of 12.5 mcg in Japanese cancer patients with pain receiving morphine preparations equivalent to less than 45 mg/day of oral morphine (less than 30 mg for suppository, less than 15 mg for injection), oral oxycodone preparations equivalent to less than 30 mg/day, or fentanyl citrate injectable solution equivalent to less than 0.3 mg/day. After pre-treatment period for one to three days for evaluating the eligibility of the patients for the study, patients will use 3 patches for 10 days.

Starting from the first day of treatment with 12.5 mcg/hr patch, fentanyl will be applied to the chest, the upper arm or other appropriate site, which will be replaced with a new patch every three days (ca. 72 hr). Total treatment duration is ten days, and dose adjustment can be allowed.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with cancer pain receiving any of the following treatments constantly for at least 3days before the treatment period :(1)Morphine preparations equivalent to less than 45 mg/day of oral morphine (or less than 30 mg/day of suppositories, or less than 15 mg/day of injectable preparations), (2)oral oxycodone preparations equivalent to less than 30 mg/day, (3)Fentanyl citrate injectable solution equivalent to less than 0.3 mg/day - Patients with a pain intensity of less than or equal to 34 mm on the 100 mm Visual Analogue Scale (VAS)
Patients with an established diagnosis of cancer of any type who have been notified of the disease
Patients may be hospitalized during application of the initial transdermal dose of fentanyl transdermal matrix patch (patients may be ambulatory after the initial patch has been replaced with the second dose)

Exclusion Criteria:

Patients with respiratory dysfunction such as chronic pulmonary disease
Patients with asthma
Patients with bradyarrhythmia
Patients with concurrent liver and/or kidney dysfunction according to the latest laboratory test values within 14 days before the start of the pre-treatment observation period
Patients with organic brain disorder such as elevated intracranial pressure, disturbance of consciousness/coma, or brain tumor
Patients with any psychoneurologic complication and judged incapable of self assessment
Patients with a history of drug dependency or narcotic abuse
Patients with a history of hypersensitivity to fentanyl or any other opioid analgesic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216658

Sponsors and Collaborators

Janssen Pharmaceutical K.K.

Investigators

Study Director:

Janssen Pharmaceutical K.K. Clinical Trial

Janssen Pharmaceutical K.K.

More Information

No publications provided

Study ID Numbers:	CR004876
Study First Received:	September 13, 2005
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00216658 History of Changes
Health Authority:	Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:

Fentanyl
Japanese patients
Cancer pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Pain, Intractable
Fentanyl
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pain
Narcotics
Pharmacologic Actions

Adjuvants, Anesthesia
Signs and Symptoms
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009