Overview

Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
0
Participant gender:
All
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 superficial vein)
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Diclofenac
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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