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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688583
• Other study ID #: CR100728
• Secondary ID: FENPAI4094FEN-KO
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2012
• Last updated: November 20, 2013
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Fentanyl matrix
Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No