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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow for 3 periods

Period 1:   Fasudil 80mg
    Sequence 1   Sequence 2   Sequence 3   Sequence 4   Sequence 5   Sequence 6
STARTED   2   4   3   2   3   3 
COMPLETED   2   4   3   2   3   3 
NOT COMPLETED   0   0   0   0   0   0 

Period 2:   Fasudil 40mg
    Sequence 1   Sequence 2   Sequence 3   Sequence 4   Sequence 5   Sequence 6
STARTED   2   4   3   2   3   3 
COMPLETED   2   4   3   2   3   3 
NOT COMPLETED   0   0   0   0   0   0 

Period 3:   Placebo
    Sequence 1   Sequence 2   Sequence 3   Sequence 4   Sequence 5   Sequence 6
STARTED   2   4   3   2   3   3 
COMPLETED   2   4   3   2   3   3 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Men and women between ages 18–80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study.

Reporting Groups
  Description
3 Period Crossover Study ( All 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.


Baseline Measures
   3 Period Crossover Study ( All Participants) 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Years]
Mean (Full Range)
 51 
 (30 to 70) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   15 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures

1.  Primary:   The Time to Recover 50% of Fall in the Baseline Skin Temperature.   [ Time Frame: within 60 minutes ]

2.  Primary:   Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.   [ Time Frame: within 60 minutes ]

3.  Secondary:   The Blood Flow by Laser Doppler Scans of the Fingers   [ Time Frame: Blood flow prior to cold challenge 2 hours after taking study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: gleathe@jhmi.edu



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