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

Osteoarthritis Clinical Trial

Official title:
Evaluation of Efficacy and Safety of TTS-Fentanyl in Moderate to Severe Pain in Osteoarthritis Patients

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

Clinical Trial 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 following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01774929
Study type Interventional
Source Janssen-Cilag Ltd.,Thailand
Contact
Status Completed
Phase Phase 4
Start date October 2008
Completion date April 2009
View Details
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