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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Intractable
• Intervention / Treatment: Drug: fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient's global assessments of pain

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 24, 2011
• Last Update Submitted That Met QC Criteria: January 20, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Fentanyl; Cancer pain; Japanese patients
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Intractable; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: CR004876