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CompletedNCT00377806Updated Dec 10, 2007

Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

A Phase 4 interventional study of Diclofenac gel in Superficial Thrombophlebitis of the Upper Limb, sponsored by Novartis. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-12-10.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Superficial Thrombophlebitis of the Upper Limb

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Keywords

  • Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs
03

In context

Thrombophlebitis

15 studies on the registry are indexed under Thrombophlebitis; 2 are open to participants now.

This study's enrollment of 200 is above the median of 104 across 11 interventional studies indexed under Thrombophlebitis.

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Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
200 participants

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Novartis
    Nürnberg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00377806
Lead sponsor
Novartis
First posted
Sep 18, 2006
Start date
Jan 2003
Completion
Sep 2006
Last update
Dec 10, 2007

Study contacts

Novartis Pharmaceuticals
principal investigator · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Diclofenac

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