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

Phase 4

Completed

• Conditions: Osteoarthritis; Low Back Pain
• Interventions: Drug: Fentanyl

• Registration Number: NCT01795898
• Lead Sponsor: Janssen Pharmaceutica

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-21
• Results First Submitted: 2013-03-18
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-10
• Last Update Submitted: 2013-06-10
• Results First Posted: 2013-07-15
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fentanyl transdermal patch	Fentanyl	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).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30	Baseline and Day 30	BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30	Baseline and Day 30	BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.
Number of Participants Requiring Rescue Medication	Day 30	Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication.
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician	Day 30	CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant	Day 30	CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.