Clinical Trial: Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Thrombophlebiti
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 superficial vein)
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)
Original Primary Outcome: Same as current
Current 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
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: September 15, 2006
Date Started: January 2003
Date Completion:
Last Updated: December 7, 2007
Last Verified: December 2007
