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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01688583
First received: September 17, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Chronic Pain
Drug: Fentanyl matrix
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).


Secondary Outcome Measures:
  • The change from baseline in mean pain intensity [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  • The difference between the patient's pain treatment goal set at baseline [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 degree of Interference with Social Life Performance due to Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 410
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688583

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
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01688583     History of Changes
Other Study ID Numbers: CR100728, FENPAI4094, FEN-KOR-5045
Study First Received: September 17, 2012
Last Updated: November 20, 2013
Health Authority: Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Chronic pain
Chronic non-cancer pain
Fentanyl matrix
Transdermal system

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 01, 2014