Topical Diclofenac Gel in Patients With Superficial Infla... | NCT00377806

Studies
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

NCT00377806

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 10, 2007Estimated

Enrollment

200

Phase

Phase 4

Conditions

Superficial Thrombophlebitis of the Upper Limb

Interventions

Diclofenac gel

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Sep 2006Actual

First Submitted Date

Sep 15, 2006

First Submission Date that Met QC Criteria

Sep 15, 2006

First Posted Date

Sep 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2007

Last Update Posted Date

Dec 10, 2007Estimated

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Diclofenac gel	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		Nuremberg			Germany