Clinical trial NCT01688583: The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic pain
Chronic non-cancer pain
Fentanyl matrix
Transdermal system
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 410
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who complain of chronic pain and have pain inadequately controlled by previous treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are judged to require Fentanyl matrix administration will participate in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
timeFrame: 12 weeks
Secondary outcomes:
measure: The change from baseline in mean pain intensity
timeFrame: Baseline, Week 12
measure: The difference between the patient's pain treatment goal set at baseline
timeFrame: Baseline, Week 12
measure: The degree of night sleep disturbance due to pain
timeFrame: 12 weeks
measure: The degree of Interference with Daily Life Performance due to Pain
timeFrame: 12 weeks
measure: The degree of Interference with Social Life Performance due to Pain
timeFrame: 12 weeks
measure: The patient's global assessment of pain treatment
timeFrame: 12 weeks
measure: The investigator's global assessment of pain treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Andong
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Goyang
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju-Si
country: Korea, Republic of
city: Kwangiu
country: Korea, Republic of
city: Kwanju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Wonju-Si
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: