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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Fentanyl matrix

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 Type: Observational
• Enrollment (Actual): 410

Contacts and Locations

Study Locations

• Korea, Republic of
  • Andong, Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Goyang, Korea, Republic of
  • Incheon, Korea, Republic of
  • Jeonju-Si, Korea, Republic of
  • Kwangiu, Korea, Republic of
  • Kwanju, Korea, Republic of
  • Seoul, Korea, Republic of
  • Wonju-Si, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fentanyl matrix	Drug: Fentanyl matrix; Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 20, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Chronic pain; Chronic non-cancer pain; Fentanyl matrix; Transdermal system
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: CR100728; FENPAI4094 (Other Identifier: Janssen Korea, Ltd., Korea); FEN-KOR-5045 (Other Identifier: Janssen Korea, Ltd., Korea)