Back to resultsTopical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
Primary Purpose
Superficial Thrombophlebitis of the Upper Limb
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Diclofenac gel
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Thrombophlebitis of the Upper Limb focused on measuring Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs
Eligibility 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
Sites / Locations
- Novartis
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00377806
Brief Title
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Thrombophlebitis of the Upper Limb
Keywords
Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Diclofenac gel
Primary Outcome Measure Information:
Title
The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)
Secondary Outcome Measure Information:
Title
Patient's global assessment of drug effect at each visit
Title
Physician's global assessment of drug effect at each visit
Title
AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5
Title
AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5
Title
AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis
City
Nürnberg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
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