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Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

NCT ID: NCT00377806

Last Updated: 2007-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-09-30

Brief Summary

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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

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Conditions

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Superficial Thrombophlebitis of the Upper Limb

Keywords

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Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Diclofenac gel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: PRINCIPAL_INVESTIGATOR

Novartis Pharmaceuticals

Locations

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Novartis

Nuremberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CVOL458UDE01

Identifier Type: -

Identifier Source: org_study_id