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NCT Number: NCT01688583

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

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andong, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl matrix

Drug

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

Primary outcomes

  1. The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint

    Time frame: 12 weeks

    Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

Secondary outcomes

  1. The change from baseline in mean pain intensity

    Time frame: Baseline, Week 12

    Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  2. The difference between the patient's pain treatment goal set at baseline

    Time frame: 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).

  3. The degree of night sleep disturbance due to pain

    Time frame: 12 weeks

    Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.

  4. The degree of Interference with Daily Life Performance due to Pain

    Time frame: 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.

  5. The degree of Interference with Social Life Performance due to Pain

    Time frame: 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.

  6. The patient's global assessment of pain treatment

    Time frame: 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.

  7. The investigator's global assessment of pain treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2012
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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