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

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

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

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

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

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

More Information

No publications provided

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

Keywords provided by Novartis:

Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Peripheral Vascular Diseases
Vasculitis
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Vascular Diseases
Diclofenac
Enzyme Inhibitors
Pharmacologic Actions
Thrombosis
Embolism and Thrombosis

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Phlebitis
Cardiovascular Diseases
Venous Thrombosis
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Thrombophlebitis

ClinicalTrials.gov processed this record on November 27, 2009