Phase 4
Completed N=237
An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain
Source: ClinicalTrials.gov NCT01795898 ↗Enrolled (actual)
237
Serious AEs
2.1%
Results posted
Jul 2013
Primary outcomePrimary: Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 — 7.20; 3.83; 5.59; 5.49 Units on a scale
Summary
The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino participants with osteoarthritis (disorder which is seen mostly in older persons in which the joints become painful and stiff) and chronic (lasting a long time) low back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 |
7.20; 3.83; 5.59; 5.49; -5.000; -3.049 | — |
| PRIMARY Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 |
5.73; 4.94; 5.25; 5.34; 4.33; 5.05 | — |
| PRIMARY Number of Participants Requiring Rescue Medication |
41 | — |
| PRIMARY Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician |
1; 5; 16; 30; 151 | — |
| PRIMARY Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant |
1; 1; 5; 14; 33; 149 | — |
Eligibility Criteria
Inclusion Criteria
- Participants diagnosed with osteoarthritis and chronic low back pain
- 3 months of persistent moderate to severe pain levels
- More than 3 times a week frequency or daily moderate to severe pain
- Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical pain scale) Exclusion Criteria
- History of allergy to fentanyl transdermal patch or its components and history of illicit drug use for the past 3 months
- Active skin disease preventing application of the transdermal system
- Chronic pulmonary disease (lung disorder)
- Participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention
- Pregnant and breastfeeding mothers
Data sourced from ClinicalTrials.gov (NCT01795898). 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.