Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins - Full Text View

Purpose

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)

Condition	Intervention	Phase
Superficial Thrombophlebitis of the Upper Limb	Drug: Diclofenac gel	Phase IV

MedlinePlus related topics:

Thrombophlebitis

ChemIDplus related topics:

Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

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

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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome 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

Estimated Enrollment:	200
Study Start Date:	January 2003
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377806

Locations


Germany
	Novartis
	Nürnberg, Germany

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis Pharmaceuticals	Novartis

More Information

Study ID Numbers:	CVOL458UDE01
First Received:	September 15, 2006
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00377806
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs

Study placed in the following topic categories:

Embolism and Thrombosis

Vasculitis

Peripheral Vascular Diseases

Embolism

Phlebitis

Vascular Diseases

Diclofenac

Venous Thrombosis

Thrombosis

Inflammation

Thrombophlebitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Cardiovascular Diseases

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00377806