The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.
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.
Study Type
OBSERVATIONAL
Enrollment
410
Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
Unnamed facility
Andong, South Korea
Unnamed facility
Busan, South Korea
Unnamed facility
Daegu, South Korea
Unnamed facility
Daejeon, South Korea
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).
Time frame: 12 weeks
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Unnamed facility
Goyang, South Korea
Unnamed facility
Incheon, South Korea
Unnamed facility
Jeonju, South Korea
Unnamed facility
Kwangiu, South Korea
Unnamed facility
Kwanju, South Korea
Unnamed facility
Seoul, South Korea
...and 1 more locations
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks