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

Tracking Information

First Received Date ^ICMJE

September 15, 2006

Last Updated Date

December 7, 2007

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00377806 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Superficial Thrombophlebitis of the Upper Limb

Intervention ^ICMJE

Drug: Diclofenac gel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

September 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00377806

Responsible Party

Study ID Numbers ^ICMJE

CVOL458UDE01

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP