Trial Outcomes & Findings for A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon (NCT NCT00498615)
NCT ID: NCT00498615
Last Updated: 2014-11-04
Results Overview
The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
17 participants
Primary outcome timeframe
within 60 minutes
Results posted on
2014-11-04
Participant Flow
Participant milestones
| Measure |
Sequence 1
Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods.
|
Sequence 2
Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
|
Sequence 3
Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
|
Sequence 4
Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
|
Sequence 5
Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
|
Sequence 6
Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
|
|---|---|---|---|---|---|---|
|
Fasudil 80mg
STARTED
|
2
|
4
|
3
|
2
|
3
|
3
|
|
Fasudil 80mg
COMPLETED
|
2
|
4
|
3
|
2
|
3
|
3
|
|
Fasudil 80mg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fasudil 40mg
STARTED
|
2
|
4
|
3
|
2
|
3
|
3
|
|
Fasudil 40mg
COMPLETED
|
2
|
4
|
3
|
2
|
3
|
3
|
|
Fasudil 40mg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo
STARTED
|
2
|
4
|
3
|
2
|
3
|
3
|
|
Placebo
COMPLETED
|
2
|
4
|
3
|
2
|
3
|
3
|
|
Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon
Baseline characteristics by cohort
| Measure |
3 Period Crossover Study ( All Participants)
n=17 Participants
This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge.
Men and women between ages 18-80 years with a clinical diagnosis of RP secondary to SSc were eligible for the study.
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 60 minutesThe time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.
Outcome measures
| Measure |
40 mg Fasudil
n=17 Participants
This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
|
80 mg Fasudil
n=17 Participants
participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
|
Placebo
n=17 Participants
participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
|
|---|---|---|---|
|
The Time to Recover 50% of Fall in the Baseline Skin Temperature.
|
7.5 minutes
Standard Deviation 3.2
|
8.2 minutes
Standard Deviation 3.0
|
7.9 minutes
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: within 60 minutesThe time to recover 70% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.
Outcome measures
| Measure |
40 mg Fasudil
n=17 Participants
This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
|
80 mg Fasudil
n=17 Participants
participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
|
Placebo
n=17 Participants
participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
|
|---|---|---|---|
|
Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.
|
17.1 minutes
Standard Deviation 10.8
|
15.0 minutes
Standard Deviation 9.4
|
18.2 minutes
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Blood flow prior to cold challenge 2 hours after taking study drugThe measurement of the blood flow of participants prior to cold challenge 2 hours after receiving study.
Outcome measures
| Measure |
40 mg Fasudil
n=17 Participants
This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
|
80 mg Fasudil
n=17 Participants
participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
|
Placebo
n=17 Participants
participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
|
|---|---|---|---|
|
The Blood Flow by Laser Doppler Scans of the Fingers
|
138.3 perfusion units
Standard Deviation 55.1
|
134.1 perfusion units
Standard Deviation 73.4
|
122.6 perfusion units
Standard Deviation 57.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
40 mg Fasudil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
80mg Fasudil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place