Superficial Thrombophlebitis of the Upper LimbPhase 4NCT00377806
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
A Phase 4 study testing Diclofenac gel in people with Superficial Thrombophlebitis of the Upper Limb, run by Novartis at 1 site in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Superficial Thrombophlebitis of the Upper Limb
- What is being tested?
- Diclofenac gel
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb
- Spontaneous or iatrogenic superficial thrombophebitis of the upper limb
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
- Being tested
- Diclofenac gel
- Keywords
- Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac gelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startJan 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Thrombophlebitis of the Upper LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Principal investigator, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377806
- Sponsor's protocol ID
- CVOL458UDE01
- Status last verified
- Dec 2007
- First submitted
- 15 Sep 2006
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00377806
- Acronym / sponsor ID
- CVOL458UDE01
- Keywords
- Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Sep 2006 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb
- Spontaneous or iatrogenic superficial thrombophebitis of the upper limb
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac gel | Drug | – |
Primary outcome
The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals principal investigator
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac gel in people with Superficial Thrombophlebitis of the Upper Limb, run by Novartis at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2007.