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

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Fentanyl matrix

• Registration Number: NCT01688583
• Lead Sponsor: Janssen Korea, Ltd., Korea

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fentanyl matrix	Fentanyl matrix	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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 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).