An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain
CompletedPhase 4NCT01816243
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Evaluation Study of Efficacy and Safety of TTS-Fentanyl in Chronic Non-Malignant Pain
- Conditions
- Interventions
- Drug: TTS-Fentanyl
- Drug: Morphine
- Sponsor
- Janssen-Cilag Ltd.,Thailand
- Start date
- 2004-04
- Primary completion
- 2008-03
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Thailand
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01816243