Efficacy and Safety Study of Transdermal Therapeutic System (TTS) Fentanyl in Participants With Osteoarthritis Knee Pain

NCT01742897 | Completed Phase 4 Results

• 2 other identifiers: CR014524FENPAI4052
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff) participants with moderate to severe pain.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Transdermal therapeutic system (TTS) fentanyl; Durogesic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30

  The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst).

  Baseline, Day 30

Study Arms (1)

TTS-fentanyl

EXPERIMENTAL

Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.

Drug: TTS-fentanyl

Interventions

TTS-fentanyl DRUG

Also known as: Durogesic

TTS-fentanyl

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic (lasting a long time) primary osteoarthritis knee pain, one or two side with stage II Kellgen-Lawrence, for more than 3 months with Visual Analogue Scale (VAS) more than 4
• Good knee deformity, no limit range of motion
• Participant who has signed the informed consent form

You may not qualify if:

• Skin disease that prevents the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability
• History or suspicion of alcohol or drug abuse within the past 5 years
• History of cardiac, nervous system or respiratory disease which in the investigator's judgment prevents participation in the study because of the potential for respiratory depression
• Confusion, reduced level of consciousness, or concomitant psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial
• Participants who do not understand or speak Thai

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead

Study Sites (1)

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Medical Affairs, Janssen-Cilag (Thailand)

662-739-7200

Study Officials

• Janssen-Cilag Ltd., Thailand Clinical Trial

  Janssen-Cilag Ltd.,Thailand

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: December 4, 2012
• First Posted: December 6, 2012
• Study Start: August 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 3, 2013
• Results First Posted: July 3, 2013

Record last verified: 2013-05

Locations

TH (1)