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

NCT00216658 | Completed Phase 2

• 1 other identifier: CR004876
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain, Intractable

Keywords

Fentanyl; Cancer pain; Japanese patients

Outcome Measures

Primary Outcomes (1)

• Patient's global assessments of pain

Secondary Outcomes (1)

• 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

Interventions

fentanyl DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

MeSH Terms

Conditions

Pain, Intractable; Cancer Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2004
• Study Completion: September 1, 2005
• Last Updated: January 24, 2011

Record last verified: 2011-01