Chronic Pain
Conditions
Keywords
Chronic pain, Chronic non-cancer pain, Fentanyl matrix, Transdermal system
Brief summary
The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.
Detailed description
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.
Interventions
DRUGFentanyl matrix
Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint | 12 weeks | Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference between the patient's pain treatment goal set at baseline | Baseline, Week 12 | 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). |
| The degree of night sleep disturbance due to pain | 12 weeks | Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete. |
| The degree of Interference with Daily Life Performance due to Pain | 12 weeks | 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. |
| The change from baseline in mean pain intensity | Baseline, Week 12 | Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). |
| The patient's global assessment of pain treatment | 12 weeks | 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. |
| The investigator's global assessment of pain treatment | 12 weeks | 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. |
| The degree of Interference with Social Life Performance due to Pain | 12 weeks | 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. |
Countries
South Korea
Outcome results
None listed