Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Phase 4

Completed

• Conditions: Superficial Thrombophlebitis of the Upper Limb

• Registration Number: NCT00377806
• Lead Sponsor: Novartis

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-01
• Study Completion: 2006-09
• Study First Submitted: 2006-09-15
• Study First Submitted QC: 2006-09-15
• Study First Posted: 2006-09-18
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-07
• Last Update Posted: 2007-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis; 🇩🇪 Nürnberg, Germany