Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00377806

Enrollment

200

Registered

2006-09-18

Start date

2003-01-31

Completion date

2006-09-30

Last updated

2007-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial Thrombophlebitis of the Upper Limb

Keywords

Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs

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)

Interventions

DRUGDiclofenac gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026