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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Chronic Pain

Treatments: Drug: Fentanyl matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT01688583

FEN-KOR-5045 (Other Identifier)

CR100728

FENPAI4094 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 410 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

410 participants in 1 patient group

Fentanyl matrix

Treatment:

Drug: Fentanyl matrix