An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: TTS-Fentanyl; Morphine
Intervention description: Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. The study duration will be 30 days after first patch application.; Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate dose titration. It is expected that most of the participants will be titrated to an appropriate dose of TTS-fentanyl within 1 week.
Intervention MeSH terms: Fentanyl; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Pain; Chronic Non-Malignant Pain; TTS-fentanyl; Durogesic

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic
      System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so
      the drug will enter the body through the skin) in Thai participants with chronic (lasting a
      long time) non-malignant (non-cancerous) pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with chronic non-malignant pain (of any etiology except for headaches or
             central spinal cord mediated pain) with moderate (medium level of seriousness) to
             severe (very serious, life threatening) pain that requires treatment with a potent
             opioid

          -  Participants must also be currently treated with short or long acting opioid
             medications other than Transdermal Therapeutic System (TTS)-fentanyl at a dose less
             than or equal to 134 milligram per day (mg/day) of oral morphine (or an equianalgesic
             dose of another opioid), participants may have been treated with TTS-fentanyl in the
             past

          -  Participants who had side effects after receiving Non Steroidal Anti-inflammatory
             Drugs (NSAIDs)

          -  Participants who failed from other treatments such as operation or lack of efficacy of
             current treatment

          -  Participants with spinal cord stimulators may enroll, provided that they turn the
             spinal cord stimulator off for the duration of the trial, or leave it continually on
             for the duration of the trial

        Exclusion Criteria:

          -  History of allergy, hypersensitivity, or lack of ability to tolerate fentanyl

          -  Skin disease that precludes the use of the transdermal system or which could affect
             the absorption of fentanyl or local tolerability

          -  History or suspicion of alcohol or drug abuse within the past 5 years

          -  History of narcotic (strong habit-forming drug that stops pain and depresses the
             central nervous system) therapy

          -  Pregnancy or breast-feeding female