Superficial Thrombophlebitis of the Upper Limb Clinical Trial
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
| Verified date | December 2007 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis | Nürnberg |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein) | |||
| Secondary | Patient's global assessment of drug effect at each visit | |||
| Secondary | Physician's global assessment of drug effect at each visit | |||
| Secondary | AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5 | |||
| Secondary | AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5 | |||
| Secondary | AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5 |