The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement
NCT ID: NCT01688583
Last Updated: 2013-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
410 participants
OBSERVATIONAL
2011-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fentanyl matrix
Fentanyl matrix
Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
Interventions
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Fentanyl matrix
Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
Eligibility Criteria
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Inclusion Criteria
* Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
* Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
* Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
* A written informed consent for study participation
Exclusion Criteria
* No previous experience of use of narcotic analgesics
* Past or current history of alcohol or drug abuse
* Cannot use transdermal analgesics due to skin disorder
* Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator
20 Years
ALL
No
Sponsors
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Janssen Korea, Ltd., Korea
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Korea, Ltd., Korea Clinical Trial
Role: STUDY_DIRECTOR
Janssen Korea, Ltd., Korea
Locations
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Andong, , South Korea
Busan, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Goyang, , South Korea
Incheon, , South Korea
Jeonju, , South Korea
Kwangiu, , South Korea
Kwanju, , South Korea
Seoul, , South Korea
Wŏnju, , South Korea
Countries
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Other Identifiers
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FENPAI4094
Identifier Type: OTHER
Identifier Source: secondary_id
FEN-KOR-5045
Identifier Type: OTHER
Identifier Source: secondary_id
CR100728
Identifier Type: -
Identifier Source: org_study_id