Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236366
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-10-07
Brief Title:
A Study of the Effect on Pain Control of Treatment With Fentanyl Administered Through the Skin Compared With Placebo in Patients With Osteoarthritis
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Randomised Double-Blind Placebo-Controlled Parallel-Group Multicentre Trial To Investigate Durogesic In Comparison To Placebo In Subjects With Moderate To Severe Pain Induced By Osteoarthritis Of The Hip Or The Knee Who Are In Need Of And Waiting For Hip Or Knee Replacement
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine if fentanyl delivered through the skin via an adhesive patch has a superior pain-relieving effect compared with placebo in patients with osteoarthritis pain that is inadequately controlled by therapeutic treatment with weak opioids which are often taken in combination with non-opioid analgesics
Detailed Description:
Chronic non-cancer pain may result from injury or illness such as osteoarthritis or rheumatoid arthritis which causes suffering and a reduction in the quality of life Opioids such as fentanyl are beneficial as potent pain-relieving drugs in patients with continuous pain This is double-blind parallel-group placebo-controlled study to compare pain relief and the effect on safety functionality and quality of life during treatment with fentanyl administered through the skin via adhesive patches transdermal system with therapy with placebo in patients with osteoarthritis OA Specifically patients with moderate to severe pain induced by osteoarthritis and for whom treatment with traditional pain medication according to the World Health Organization WHO pain ladder up to and including weak opioids has failed to provide adequate pain relief are eligible to enroll After screening patients enter a 1-week Run-In period in which prior treatment with weak opioids with or without non-opioid pain medication continues After this period patients with moderate to severe pain are randomized to the fentanyl adhesive patch or placebo during the Double-Blind Treatment phase for 6 weeks All patients including those who discontinue or withdraw from the study enter the Tapering-Off period during which the medication is reduced gradually Assessments of effectiveness include Pain relief determined with a Visual Analogue Scale VAS by means of an electronic pain diary updated by the patient at least twice daily functionality assessed by the Western Ontario and McMaster Universities WOMAC Osteoarthritis Index and quality of life measured by the SF-36 Quality of Life Questionnaire Safety assessments include identification of possible withdrawal symptoms at the end of the Tapering-Off period measurement of vital signs at stated intervals and incidence of adverse events throughout the study The study hypothesis is that patients with osteoarthritis of the hip or knee whose pain is not adequately controlled by other pain-relieving medications will show an improvement in pain control after treatment with the fentanyl transdermal system Fentanyl patches to deliver 25 microgramshour to 100 microgramshour changed every 3 days for 6 weeks doses may be adjusted for adequate pain control anti-nausea tablets Metoclopramide 10 milligramsmg and paracetamol tablets 500 mg maximum 4 gramsday as supplementary pain control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None