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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bangkok, Thailand

About this study

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, prospective study (study following participants forward in time) of TTS-fentanyl matrix form in knee osteoarthritis participants. The study consists of 3 phases: a screening phase, an open label treatment phase consisting of 2 periods, and an evaluation phase. The first patch will be applied on the first day of treatment phase by the investigator, and sufficient patches until Day 30 will be provided to the participant with the instructions to apply the patch. The TTS-fentanyl dose will normally be increased, if needed by 12.5 microgram per hour taking into account the daily dose of supplemental paracetamol required by the participant. Efficacy with regard to pain control will be recorded principally by the participant via questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

TTS-fentanyl

Drug

Other names: Durogesic

Primary outcomes

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

Time frame: Baseline, 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).

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.,Thailand

Industry

Registry information

Official study title

Evaluation of Efficacy and Safety of TTS-Fentanyl in Moderate to Severe Pain From Knee Osteoarthritis

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Dec 6, 2012
Registry last updated: Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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