NCT00377806

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
Last Updated

December 10, 2007

Status Verified

December 1, 2007

First QC Date

September 15, 2006

Last Update Submit

December 7, 2007

Conditions

Superficial Thrombophlebitis of the Upper Limb

Keywords

Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs

Outcome Measures

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 (5)

  • 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

Interventions

Diclofenac gelDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb
  • Spontaneous or iatrogenic superficial thrombophebitis of the upper limb

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Nuremberg, Germany

Location

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 18, 2006

Study Start

January 1, 2003

Study Completion

September 1, 2006

Last Updated

December 10, 2007

Record last verified: 2007-12

Locations

DE(1)