Status:
COMPLETED
An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain
Lead Sponsor:
Janssen Pharmaceutica
Conditions:
Osteoarthritis
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded") single-arm and prospective study (study fol...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT01795898
Start Date
January 1 2009
End Date
September 1 2009
Last Update
July 15 2013
Active Locations (1)
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1
Quezon City, Philippines