Raynaud DiseasePhase 2NCT00251238
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
A Phase 2 study testing Ginkgo biloba extract EGb 761 in people with Raynaud Disease, run by VSM Geneesmiddelen b.v. at 1 site in Netherlands.
Trial summary
The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Raynaud Disease
- What is being tested?
- Ginkgo biloba extract EGb 761
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Raynaud´s phenomenon
- History of episodic digital or toe pallor
- Duration of Raynaud´s phenomenon at least 2 years
- Suffering form regular occuring attacks prior to enrolment
Who cannot join
- Secondary Raynaud´s phenomenon
- Connective tissue disease
- Large vessel disease
- Cryoglobulinemia, cold agglutinins disease, thrombocytosis
- Concomitant pharmacological treatment with effects on the vasculature
- Pregnancy or lactation
- Severe internal or systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon
The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.
Read the detailed description
Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s phenomenon are discussed and fall into the following three categories:
- neurological malfunction
- pathological blood vessel wall and blood cell interactions
- inflammatory and immunological responses Based on these concepts different classes of drugs have been tested. Although some therapies have shown effects, prolongation of the therapy is often difficult due to side-effects.
Considering a prevalence of 5-10% in the general population, there is still a place and probably a need for the development of new treatment concepts. Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities. In a small placebo controlled trial in patients with the Raynaud´s phenomenon promising results for the Ginkgo biloba extract were shown. EGb 761® is known to be safe and well tolerated. Based on the above considerations, EGb 761® may be an effective treatment for Raynaud´s phenomenon.
Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.
- Conditions
- Raynaud Disease
- Being tested
- Ginkgo biloba extract EGb 761
- Keywords
- Raynaud´s phenomenon, Vasospastic attacks, Ginkgo biloba
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo biloba extract EGb 761Drug
Also called Ginkgo biloba
daily Ginkgo biloba extract EGb 761
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo biloba extract EGb 761 | Experimental | Receiving daily Ginkgo biloba extract EGb 761 Receives: Drug: Ginkgo biloba extract EGb 761 |
| Placebo | Placebo comparator | Receiving daily placebo Receives: Drug: Ginkgo biloba extract EGb 761 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Vasospastic Attacks
Measured: Number of Vasospastic Attacks per day, for up to 10 weeks
Duration of Vasospastic Attacks
Measured: minutes per day
Change From Baseline in Severity of Vasospastic Attacks
Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale.
The scale ranged between 0 and 10, with higher scores indicating more severe attacks.
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Raynaud DiseaseStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- VSM Geneesmiddelen b.v.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.
- Investigators
- Study Department, Study director, VSM Geneesmiddelen b.v.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251238
- Sponsor's protocol ID
- 523052.01.002
- Status last verified
- May 2017
- First submitted
- 8 Nov 2005
- Last updated
- 22 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Ginkgo Biloba Extract EGb 761® in Patients With Raynaud´s Phenomenon
- ClinicalTrials.gov ID
- NCT00251238
- Acronym / sponsor ID
- 523052.01.002
- Conditions
- Raynaud Disease
- Keywords
- Raynaud´s phenomenon, Vasospastic attacks, Ginkgo biloba
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- VSM Geneesmiddelen b.v.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 9 Nov 2005 (estimated)
- Results
- Posted 22 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.
Detailed description
Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s phenomenon are discussed and fall into the following three categories:
- neurological malfunction
- pathological blood vessel wall and blood cell interactions
- inflammatory and immunological responses Based on these concepts different classes of drugs have been tested. Although some therapies have shown effects, prolongation of the therapy is often difficult due to side-effects.
Considering a prevalence of 5-10% in the general population, there is still a place and probably a need for the development of new treatment concepts. Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities. In a small placebo controlled trial in patients with the Raynaud´s phenomenon promising results for the Ginkgo biloba extract were shown. EGb 761® is known to be safe and well tolerated. Based on the above considerations, EGb 761® may be an effective treatment for Raynaud´s phenomenon.
Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginkgo biloba extract EGb 761 | Experimental | Drug: Ginkgo biloba extract EGb 761Receiving daily Ginkgo biloba extract EGb 761 |
| Placebo | Placebo comparator | Drug: Ginkgo biloba extract EGb 761Receiving daily placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Raynaud´s phenomenon
- History of episodic digital or toe pallor
- Duration of Raynaud´s phenomenon at least 2 years
- Suffering form regular occuring attacks prior to enrolment
Key exclusion criteria (7 listed)
- Secondary Raynaud´s phenomenon
- Connective tissue disease
- Large vessel disease
- Cryoglobulinemia, cold agglutinins disease, thrombocytosis
- Concomitant pharmacological treatment with effects on the vasculature
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 |
|---|---|---|
| Ginkgo biloba extract EGb 761Also: Ginkgo bilobadaily Ginkgo biloba extract EGb 761 | Drug | Ginkgo biloba extract EGb 761, Placebo |
Primary outcome
Frequency of Vasospastic Attacks
Time frame: Number of Vasospastic Attacks per day, for up to 10 weeks
Duration of Vasospastic Attacks
Time frame: minutes per day
Change From Baseline in Severity of Vasospastic Attacks
Time frame: Baseline and 10 weeks
Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale. The scale ranged between 0 and 10, with higher scores indicating more severe attacks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Study Department study director
VSM Geneesmiddelen b.v.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginkgo biloba extract EGb 761 in people with Raynaud Disease, run by VSM Geneesmiddelen b.v. at 1 site in Netherlands.
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 4 inclusion and 7 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 22 May 2017. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Vasospastic Attacks (time frame: Number of Vasospastic Attacks per day, for up to 10 weeks). The study lists 3 primary outcomes in all. 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 22 May 2017.