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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier:
NCT01742897
First received: December 4, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: TTS-fentanyl
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of TTS-Fentanyl in Moderate to Severe Pain From Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.,Thailand:

Primary Outcome Measures:
  • Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 [ Time Frame: Baseline, Day 30 ] [ Designated as safety issue: No ]
    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).


Enrollment: 35
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TTS-fentanyl
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
Other Name: Durogesic

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, 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742897

Locations
Thailand
Bangkok, Thailand
Sponsors and Collaborators
Janssen-Cilag Ltd.,Thailand
Investigators
Study Director: Janssen-Cilag Ltd., Thailand Clinical Trial Janssen-Cilag Ltd.,Thailand
  More Information

No publications provided

Responsible Party: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT01742897     History of Changes
Other Study ID Numbers: CR014524, FENPAI4052
Study First Received: December 4, 2012
Results First Received: January 21, 2013
Last Updated: May 29, 2013
Health Authority: Thailand: Food and Drug Administration
Thailand: Ministry of Public Health

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Osteoarthritis, Knee
Transdermal therapeutic system (TTS) fentanyl
Durogesic

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014