Phase 4
Completed N=39
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain
Source: ClinicalTrials.gov NCT01816243 ↗Enrolled (actual)
39
Serious AEs
2.6%
Results posted
Jun 2013
Primary outcomePrimary: Change From Baseline in Pain Intensity Rating at Day 15 — -1.56 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Intensity Rating at Day 15 |
-1.56 | — |
| PRIMARY Change From Baseline in Pain Intensity Rating at Day 30 |
-1.95 | — |
| SECONDARY Number of Participants With Investigator's Global Assessment |
0; 0; 1; 0; 7; 2 | — |
| SECONDARY Number of Participants With Participant's Global Assessment |
1; 0; 2; 1; 4; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT01816243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.