Trial Outcomes & Findings for Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon (NCT NCT00251238)
NCT ID: NCT00251238
Last Updated: 2017-05-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Number of Vasospastic Attacks per day, for up to 10 weeks
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
Intervention Group
active treatment group, receiving oral film-coated tablet of 120-mg Ginkgo Biloba special extract (EGb 761) 2 times a day for 10 weeks, after an initial 2-week run-in phase
|
Placebo Group
receiving matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon
Baseline characteristics by cohort
| Measure |
Intervention Group
n=21 Participants
active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks
|
Control Group
n=20 Participants
Receiving matching placebo
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 13 • n=99 Participants
|
49 years
STANDARD_DEVIATION 13 • n=107 Participants
|
48 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Number of Vasospastic Attacks per day, for up to 10 weeksOutcome measures
| Measure |
Intervention Group
n=21 Participants
active treatment group (EGb 761)
|
Placebo Group
n=20 Participants
receiving placebo
|
|---|---|---|
|
Frequency of Vasospastic Attacks
|
2.4 attacks per day
Standard Deviation 2.6
|
2.0 attacks per day
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: minutes per dayOutcome measures
| Measure |
Intervention Group
n=21 Participants
active treatment group (EGb 761)
|
Placebo Group
n=20 Participants
receiving placebo
|
|---|---|---|
|
Duration of Vasospastic Attacks
|
47.4 minutes
Standard Deviation 63.0
|
50.9 minutes
Standard Deviation 84.7
|
PRIMARY outcome
Timeframe: Baseline and 10 weeksSeverity 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.
Outcome measures
| Measure |
Intervention Group
n=21 Participants
active treatment group (EGb 761)
|
Placebo Group
n=20 Participants
receiving placebo
|
|---|---|---|
|
Change From Baseline in Severity of Vasospastic Attacks
|
-1.3 units on a scale
Standard Deviation 2.3
|
-1.3 units on a scale
Standard Deviation 2.4
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=21 participants at risk
active treatment group (EGb 761)
|
Placebo Group
n=20 participants at risk
receiving placebo
|
|---|---|---|
|
Nervous system disorders
headache
|
9.5%
2/21 • Number of events 2 • 1 year
|
10.0%
2/20 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoe
|
4.8%
1/21 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
Additional Information
Dr. SJH Bredie, MD, PhD
Radboud University Nijmegen, The Netherlands
Phone: 0031 24 3618819
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place