Phase 4
Completed N=35
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis
Source: ClinicalTrials.gov NCT01774929 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Pain Intensity Score at Day 15 — 6.61 cm
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 participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Score at Day 15 |
6.61 | — |
| PRIMARY Pain Intensity Score at Day 30 |
6.00 | — |
| SECONDARY Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 |
17.04; 14.84; 13.41 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic (lasting a long time) primary osteoarthritis pain for more than 3 months with Visual Analog Scale (VAS) greater than or equal to 5
- Participants having moderate to severe pain (VAS greater than or equal to 5), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 150 milligram [mg] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days
- Participants who failed from other treatments such as operation or lack of efficacy of current treatment
Exclusion Criteria
- Skin disease that prevents 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 cardiac, nervous system or respiratory disease which in the investigator's judgment precludes participation in the study because of the potential for respiratory depression
- Confusion, reduced level of consciousness, or concomitant (given at the same time) psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial
- Pregnant or breast-feeding female; female participants of child bearing potential without adequate contraception
Data sourced from ClinicalTrials.gov (NCT01774929). 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.