- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377806
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
December 7, 2007 updated by: Novartis
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
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)
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nürnberg, Germany
- Novartis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)
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Secondary Outcome Measures
Outcome Measure |
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Patient's global assessment of drug effect at each visit
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Physician's global assessment of drug effect at each visit
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AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5
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AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5
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AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
September 15, 2006
First Submitted That Met QC Criteria
September 15, 2006
First Posted (Estimate)
September 18, 2006
Study Record Updates
Last Update Posted (Estimate)
December 10, 2007
Last Update Submitted That Met QC Criteria
December 7, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Vasculitis
- Venous Thrombosis
- Thrombosis
- Peripheral Vascular Diseases
- Phlebitis
- Thrombophlebitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- CVOL458UDE01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Superficial Thrombophlebitis of the Upper Limb
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University of OklahomaPfizerCompletedSuperficial Thrombophlebitis | Upper Extremity Superficial Thrombophlebitis | Lower Extremity Superficial ThrombophlebitisUnited States
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Mansoura UniversityCompletedSurgery to the Distal One Third of the Upper LimbEgypt
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Centre Hospitalier Universitaire DijonCompletedPatient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower LimbFrance
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Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingAmputation | Amputation; Traumatic, Limb | Upper Limb Amputation at the Hand | Upper Limb Amputation at the WristUnited States
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Federal University of Espirito SantoEnrolling by invitationUpper Limb Amputation at the HandBrazil
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Shirley Ryan AbilityLabCoapt, LLCRecruitingLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Phantom Limb Pain | Phantom Pain | Phantom Sensation | Lower Limb Amputation Knee | Lower Limb Amputation at Ankle (Injury) | Upper Limb Amputation at the Hand | Upper Limb Amputation at the Wrist | Upper... and other conditionsUnited States
Clinical Trials on Diclofenac gel
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