The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement
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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 |
- 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).
- 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.
| Estimated Enrollment: | 476 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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 |
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.
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| 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 | |
| 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: | April 22, 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:
|
Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013