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OpenTrials
Completed

NCT Number: NCT00377806

Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

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)

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Key information

Conditions

Superficial Thrombophlebitis of the Upper Limb

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Nuremberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac Gel

Drug

Primary outcomes

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

Secondary outcomes

  1. Patient's global assessment of drug effect at each visit

  2. Physician's global assessment of drug effect at each visit

  3. AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5

  4. AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5

  5. AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2006
First posted
Sep 18, 2006
Registry last updated
Dec 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.