The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.

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Detailed Description

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This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fentanyl matrix

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Complain of chronic non-cancer pain that persists for \>= 3 months
* 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

* Experience of treatment with Fentanyl matrix within the past 4 weeks
* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No