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A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

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ClinicalTrials.gov Identifier: NCT00498615
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Fredrick M. Wigley, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Raynaud
Scleroderma
Intervention Drug: Fasudil
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6
Hide Arm/Group Description 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. 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 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 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 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 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
Period Title: Fasudil 80mg
Started 2 4 3 2 3 3
Completed 2 4 3 2 3 3
Not Completed 0 0 0 0 0 0
Period Title: Fasudil 40mg
Started 2 4 3 2 3 3
Completed 2 4 3 2 3 3
Not Completed 0 0 0 0 0 0
Period Title: Placebo
Started 2 4 3 2 3 3
Completed 2 4 3 2 3 3
Not Completed 0 0 0 0 0 0
Arm/Group Title 3 Period Crossover Study ( All Participants)
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
Men and women between ages 18–80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
51
(30 to 70)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  94.1%
>=65 years
1
   5.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
15
  88.2%
Male
2
  11.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title The Time to Recover 50% of Fall in the Baseline Skin Temperature.
Hide Description 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.
Time Frame within 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 40 mg Fasudil 80 mg Fasudil Placebo
Hide Arm/Group Description:
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.
participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: minutes
7.5  (3.2) 8.2  (3.0) 7.9  (3.1)
2.Primary Outcome
Title Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.
Hide Description The 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.
Time Frame within 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fasudil 80 mg 40 mg Fasudil Placebo
Hide Arm/Group Description:

Time to recover 70% of baseline skin temperature after cold challenge done 2 hrs after dose.

Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.

Time to reach 70% skin temperature after cold challenge done 2 hrs after dosing.

Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.

Time to reach 70% of skin temperature after cold challenge done 2 hrs after taking placebo

Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.

Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: minutes
17.1  (10.8) 15.0  (9.4) 18.2  (10.7)
3.Secondary Outcome
Title The Blood Flow by Laser Doppler Scans of the Fingers
Hide Description The measurement of the blood flow of participants prior to cold challenge 2 hours after receiving study.
Time Frame Blood flow prior to cold challenge 2 hours after taking study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 80 mg Fasudil 40 mg Fasudil Placebo
Hide Arm/Group Description:

This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil In this arm participants received 80 mg of Fasudil 2 hours before a standardized cold challenge.

Men and women between ages 18–80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study.

In this group participants received 40mg of Fasudil 2 hours before cold challenge
In this group participants received placebo 2 hours before cold challenge.
Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: perfusion units
138.3  (55.1) 134.1  (73.4) 122.6  (57.6)
Time Frame 35 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 40 mg Fasudil 80mg Fasudil
Hide Arm/Group Description Placebo was administered 2 hours before a standardized cold challenge. 40 mg Fasudil was administered 2 hours before a standardized cold challenge. 80mg Fasudil was administered 2 hours before a standardized cold challenge.
All-Cause Mortality
Placebo 40 mg Fasudil 80mg Fasudil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 40 mg Fasudil 80mg Fasudil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 40 mg Fasudil 80mg Fasudil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gwen Leatherman, R.N.
Organization: Johns Hopkins University
Phone: 410-550-8582
Responsible Party: Fredrick M. Wigley, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00498615     History of Changes
Other Study ID Numbers: NA_00002801
First Submitted: July 6, 2007
First Posted: July 10, 2007
Results First Submitted: March 25, 2014
Results First Posted: November 4, 2014
Last Update Posted: November 4, 2014