Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108992
Status:
COMPLETED
Last Update Posted:
2007-01-05
First Post:
2005-04-21
Brief Title:
Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis
Sponsor:
Nuvo Research Inc
Organization:
Nuvo Research Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-01
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:
Oral non-steroidal anti-inflammatory drugs NSAIDs are a recommended treatment for the symptoms of osteoarthritis of the knee However NSAIDs may cause a range of negative side effects including stomach pain heartburn bleeding stomach ulcer and liver or kidney abnormality A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee while minimizing the side effects common to oral NSAIDs The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee
Detailed Description:
During this 12-week study patients will visit the study clinic 5 times At the screening visit the patients demographic information medical and medication history will be recorded and a physical examination performed After washout of all NSAIDsother analgesic medication the patient will return for the baseline visit During the treatment phase of the study the patient will apply a topical solution to hisher osteoarthritic knee and take an oral study tablet The patient may randomly receive active treatment with topical diclofenac oral diclofenac both or neither placebo Follow-up clinic visits are conducted at 4 8 and 12 weeks Routine laboratory analyses are done at baseline 4 and 12 weeks
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