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Tadalafil for the Treatment of Raynaud's

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Anne Laumann, Northwestern University
ClinicalTrials.gov Identifier:
NCT00822354
First received: May 31, 2008
Last updated: December 2, 2014
Last verified: December 2014
Results First Received: September 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Raynaud
Intervention: Drug: Tadalafil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tadalafil Followed by Placebo Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
Placebo Followed by Tadalafil Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.

Participant Flow for 3 periods

Period 1:   First Intervention (28 Days)
    Tadalafil Followed by Placebo     Placebo Followed by Tadalafil  
STARTED     5     5  
COMPLETED     4     5  
NOT COMPLETED     1     0  

Period 2:   Washout (7 Days)
    Tadalafil Followed by Placebo     Placebo Followed by Tadalafil  
STARTED     4     5  
COMPLETED     4     5  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (28 Days)
    Tadalafil Followed by Placebo     Placebo Followed by Tadalafil  
STARTED     4     5  
COMPLETED     3     5  
NOT COMPLETED     1     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Tadalafil Followed by Placebo Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
Placebo Followed by Tadalafil Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
Total Total of all reporting groups

Baseline Measures
    Tadalafil Followed by Placebo     Placebo Followed by Tadalafil     Total  
Number of Participants  
[units: participants]
  5     5     10  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     5     10  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     4     4     8  
Male     1     1     2  
Region of Enrollment  
[units: participants]
     
United States     5     5     10  



  Outcome Measures
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1.  Primary:   Number of Raynaud's Phenomenon Attacks Per Day   [ Time Frame: 9 weeks ]

2.  Primary:   Duration of Raynaud's Phenomenon Attacks   [ Time Frame: 9 weeks ]

3.  Primary:   Raynaud Severity Visual Analog Score (VAS)   [ Time Frame: 9 weeks ]

4.  Primary:   Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)   [ Time Frame: 9 weeks ]

5.  Secondary:   Digital Blood Pressure   [ Time Frame: 9 weeks ]

6.  Secondary:   Capillary Diameter   [ Time Frame: 9 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Clinical Trials Coordinator
Organization: Northwestern University
phone: 312-695-6829
e-mail: j-bae@northwestern.edu



Responsible Party: Anne Laumann, Northwestern University
ClinicalTrials.gov Identifier: NCT00822354     History of Changes
Other Study ID Numbers: STU1199
Study First Received: May 31, 2008
Results First Received: September 11, 2014
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board