Clinical trial NCT01795898: An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain
Official title: Efficacy, Safety and Quality of Life Outcome of Fentanyl Transdermal Patch (Durogesic-D-Trans) Among Filipino Patients With Osteoarthritis and Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Low Back Pain
Keywords: Osteoarthritis
Low back pain
Fentanyl transdermal patch
Durogesic-D-Trans
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 painful and stiff) and chronic (lasting a long time) low back pain.

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 following participants forward in time) of fentanyl in participants with osteoarthritis and Chronic low back pain with moderate (medium level of seriousness) and severe (very serious, life threatening) pain levels. Participants will be treated with fentanyl transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) starting with 12.5 microgram (mcg) dose of fentanyl. The dose will be increased on Day 3, if needed, by 12.5 mcg. Dose adjustments will be done every 3 days. Maximum of 50 mcg dose of fentanyl will be allowed. Participants will be evaluated for pain levels and quality of life using Brief pain inventory (BPI) score and Clinical global impression-severity (CGI-S) score. Tramadol 50 milligram tablet at a maximum of 6 tablets per day will be used as supplemental doses of analgesic (drug used to control pain). Participants' safety will be monitored through out the study.

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

Primary outcomes:
measure: Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30
timeFrame: Baseline and Day 30
measure: Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30
timeFrame: Baseline and Day 30
measure: Number of Participants Requiring Rescue Medication
timeFrame: Day 30
measure: Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician
timeFrame: Day 30
measure: Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Quezon City
country: Philippines
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical trial
role: STUDY_DIRECTOR
References: