- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01742897
Efficacy and Safety Study of Transdermal Therapeutic System (TTS) Fentanyl in Participants With Osteoarthritis Knee Pain
May 29, 2013 updated by: Janssen-Cilag Ltd.,Thailand
Evaluation of Efficacy and Safety of TTS-Fentanyl in Moderate to Severe Pain From Knee Osteoarthritis
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30
Time Frame: Baseline, Day 30
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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).
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Baseline, Day 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
December 4, 2012
First Submitted That Met QC Criteria
December 4, 2012
First Posted (ESTIMATE)
December 6, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 3, 2013
Last Update Submitted That Met QC Criteria
May 29, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- CR014524
- FENPAI4052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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