Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Condition(s) targeted: Superficial Thrombophlebitis of the Upper Limb

Intervention: Diclofenac gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Principal Investigator, Affiliation: Novartis

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)

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

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

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Novartis, Nürnberg, Germany

Starting date: January 2003
Ending date: September 2006
Last updated: December 7, 2007