An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis; Low Back Pain

Treatments: Drug: Fentanyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795898

CR015268

FENPAI4074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 237 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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237 participants in 1 patient group

Fentanyl transdermal patch

Experimental group

Description:

Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10).

Treatment:

Drug: Fentanyl