Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Novartis

Status and phase: Completed; Phase 4

Conditions: Superficial Thrombophlebitis of the Upper Limb

Treatments: Drug: Diclofenac gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377806

CVOL458UDE01

Details and patient eligibility

About

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)

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind