Status:
COMPLETED
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
Lead Sponsor:
Novartis
Conditions:
Superficial Thrombophlebitis of the Upper Limb
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This study will assess the efficacy, safety and tolerability of topically administered diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size of erythema along the...
Eligibility Criteria
Inclusion
- Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb
- Spontaneous or iatrogenic superficial thrombophebitis of the upper limb
Exclusion
- Hypersensitivity to the study drug, to actylsalicyclic acid and other non-steroidal antirheumatic agents and to the ingredients of the gel
- Paitents who had developed asthma, skin reactions or acute rhinitis to acetylsalicylic acid or other non-steroidal antirheumatic agents in the past
- Therapy with varicose vein remedies, antithrombotic or antiphlogistic agents as well as corticosteroids for more than 7 days prior to study start
- Acute deep vein thrombosis and thrombophlebitis extending into other deep veins
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00377806
Start Date
January 1 2003
End Date
September 1 2006
Last Update
December 10 2007
Active Locations (1)
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1
Novartis
Nuremberg, Germany