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

NCT01795898 | Completed Phase 4 Results

• 2 other identifiers: CR015268FENPAI4074
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Low Back Pain

Keywords

Osteoarthritis; Low back pain; Fentanyl transdermal patch; Durogesic-D-Trans

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Brief Pain Inventory (BPI) Severity Score at 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.

  Baseline and Day 30

• Change From Baseline in Brief Pain Inventory (BPI) Interference Score at 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.

  Baseline and Day 30

• Number of Participants Requiring Rescue Medication

  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.

  Day 30

• Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician

  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.

  Day 30

• Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant

  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.

  Day 30

Study Arms (1)

Fentanyl transdermal patch

EXPERIMENTAL

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).

Drug: Fentanyl

Interventions

Fentanyl DRUG

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).

Also known as: DUROGESIC-D-TRANS

Fentanyl transdermal patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with osteoarthritis and chronic low back pain
• months of persistent moderate to severe pain levels
• More than 3 times a week frequency or daily moderate to severe pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica: lead

Study Sites (1)

Unknown Facility

Quezon City, Philippines

Location

MeSH Terms

Conditions

Osteoarthritis; Low Back Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Affairs Manager
• Organization: Janssen Philippines

+632-8247901

Study Officials

• Janssen Pharmaceutica Clinical trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 21, 2013
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 15, 2013
• Results First Posted: July 15, 2013

Record last verified: 2013-06

Locations

PH (1)