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

Study Overview
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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.

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.

Official Title
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The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement: Multicenter, Prospective, Open-label, Observational Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Fentanyl matrix


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fentanyl matrix<br> | Drug: Fentanyl matrix<br>* Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint | Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in mean pain intensity | Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). | Baseline, Week 12 | 
| The difference between the patient's pain treatment goal set at baseline | The degree of pain the patient wishes to achieve by the end of treatment, set at baseline. The degree of pain will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). | Baseline, Week 12 | 
| The degree of night sleep disturbance due to pain | Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete. | 12 weeks | 
| The degree of Interference with Daily Life Performance due to Pain | The degree of interference with daily life performance due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Daily life performance means household work performance, etc. | 12 weeks | 
| The degree of Interference with Social Life Performance due to Pain | The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social life performance means interpersonal relationship, going out, working life, etc. | 12 weeks | 
| The patient's global assessment of pain treatment | The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study participant. | 12 weeks | 
| The investigator's global assessment of pain treatment | The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Chronic non-cancer pain, Fentanyl matrix, Transdermal system