NCT00251238

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

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

November 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
11.1 years until next milestone

Results Posted

Study results publicly available

May 22, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

November 8, 2005

Results QC Date

January 12, 2015

Last Update Submit

May 16, 2017

Conditions

Raynaud Disease

Keywords

Raynaud´s phenomenonVasospastic attacksGinkgo biloba

Outcome Measures

Primary Outcomes (3)

  • Frequency of Vasospastic Attacks

    Number of Vasospastic Attacks per day, for up to 10 weeks

  • Duration of Vasospastic Attacks

    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.

    Baseline and 10 weeks

Study Arms (2)

Ginkgo biloba extract EGb 761

EXPERIMENTAL

Receiving daily Ginkgo biloba extract EGb 761

Drug: Ginkgo biloba extract EGb 761

Placebo

PLACEBO COMPARATOR

Receiving daily placebo

Drug: Ginkgo biloba extract EGb 761

Interventions

Ginkgo biloba extract EGb 761DRUG

daily Ginkgo biloba extract EGb 761

Also known as: Ginkgo biloba
Ginkgo biloba extract EGb 761Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC ST Radboud

Nijmegen, Gelderland, 6525 GH, Netherlands

Location

MeSH Terms

Conditions

Raynaud Disease

Interventions

Ginkgo biloba extractGinkgo Extract

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. SJH Bredie, MD, PhD
Organization
Radboud University Nijmegen, The Netherlands
bas.bredie@radboudumc.nl
0031 24 3618819

Study Officials

  • Study Department

    VSM Geneesmiddelen b.v.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SJH Bredie, internist, MD, PhD

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 9, 2005

Study Start

November 1, 2005

Primary Completion

March 1, 2006

Study Completion

April 1, 2006

Last Updated

May 22, 2017

Results First Posted

May 22, 2017

Record last verified: 2017-05

Locations

NL(1)