Official Title: “A One Week, Double-Blind, Adaptive, Randomized, Multicenter Study to Compare the Efficacy, Safety and Tolerability of Topical Diclofenac Gel Versus Placebo in Patients With Superficial Thrombophlebitis”

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)

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Diclofenac gel

Primary Measures

• The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)

Secondary Measures

• Patient's global assessment of drug effect at each visit
• Physician's global assessment of drug effect at each visit
• AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5
• AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5
• AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Principal Investigator Novartis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00377806

Study ID Number: CVOL458UDE01

ClinicalTrials.gov Identifier: NCT00377806

Health Authority: Germany: Federal Institute for Drugs and Medical Devices