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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

May 31, 2008
December 2, 2014
September 2008
February 2010   (final data collection date for primary outcome measure)
  • Number of Raynaud's Phenomenon Attacks Per Day [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
  • Duration of Raynaud's Phenomenon Attacks [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day and the duration of each attack. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
  • Raynaud Severity Visual Analog Score (VAS) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents Raynaud's disease of low severity, and 100 mm (right boundary) represents extremely severe Raynaud's disease. The subject makes a vertical mark on the VAS to indicate the severity of Raynaud's disease over the past two weeks. The Raynaud's severity score is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
  • Raynaud's Condition Score (RCS) Visual Analog Scale (VAS) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents no difficulty with Raynaud's disease, and 100 mm (right boundary) represents extreme difficulty with Raynaud's disease. The subject makes a vertical mark on the VAS to indicate difficulty experienced that day with Raynaud's disease. The RCS is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Raynaud's condition score(RSC) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00822354 on ClinicalTrials.gov Archive Site
  • Digital Blood Pressure [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
  • Capillary Diameter [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.
Digital Blood Pressure [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tadalafil for the Treatment of Raynaud's
Tadalafil for the Treatment of Secondary Raynaud's Phenomenon
The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.
The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Raynaud
Drug: Tadalafil
Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil
Other Name: Cialis
  • Experimental: 1
    Subjects will receive tadalafil 20mg every other day for the first month, and then placebo for the second month.
    Intervention: Drug: Tadalafil
  • Experimental: 2
    Subjects will receive placebo for the first month, and tadalafil 20mg orally every other day for the second month.
    Intervention: Drug: Tadalafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • active Raynaud's Phenomenon
  • stable disease and medication requirements over the previous 2 months
  • subjects willing and able to participate in study assessments
  • ability to understand and sign informed consent
  • ages 18 to 65, both sexes
  • a diagnosis of diffuse or limited cutaneous sclerosis, MCTD using the American College Rheumatology criteria

Exclusion Criteria:

  • uncontrolled HTN, DM, unstable disease, angina or using oral nitrates
  • smoking, active alcoholism, drug abuse within 5 years
  • abnormal renal function
  • ulnar arterial occlusive disease as shown by a positive Allen Test
  • Pregnant or breast feeding or considering preg. in next 4 months
  • past or present major psych. illness
  • allergy or sensitivity to tadalafil
  • subject unable to understand protocol or give informed consent
  • part. in another study trial within 30 days
  • taking sildenafil
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00822354
STU1199
No
Not Provided
Not Provided
Anne Laumann, Northwestern University
Northwestern University
Eli Lilly and Company
Principal Investigator: Anne Laumann, MBChB, MRCP Northwestern University
Northwestern University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP