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Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

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ClinicalTrials.gov Identifier: NCT00626665
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : March 22, 2013
Sponsor:
Information provided by (Responsible Party):
Vikas Agarwal, Sanjay Gandhi Postgraduate Institute of Medical Sciences

Brief Summary:
In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash out period of 2 week will be observed and then the two groups will be switched over to receive the other drug. We planned a priori to include 20 patients. The concomitant medication for treatment of rheumatic disease remained unchanged during the whole study. Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO heart will be done at base line to assess the PAH and LV function and repeated at the end of the study. Blood pressure will be recorded at each visit. A physician unaware of the treatment group will record skin score and appearance of new cutaneous ulcers. The primary outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated dilatation of the brachial artery will be done at baseline 6 and 12 weeks.

Condition or disease Intervention/treatment Phase
Raynaud Disease Drug: Tadalafil Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
Study Start Date : December 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008


Arm Intervention/treatment
Placebo Comparator: Placebo
One placebo tablet every alternate day for 6 weeks
Drug: Tadalafil
Tablets Tadalafil, 20 mg, alternate days, 6 weeks
Other Name: Tadalis



Primary Outcome Measures :
  1. The primary outcome variables will be frequency and duration of Raynaud's attacks, evolution of trophic digital lesions [ Time Frame: 6 weeeks and 12 weeks ]

Secondary Outcome Measures :
  1. change in flow mediated dilatation of the brachial artery [ Time Frame: 6 weeks and 12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between the ages of 18 years and 60 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma). Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as a history of at least 4 attacks per week during two pre-trial period even with treatment with other vasodilators. The diagnosis of scleroderma is defined by the American College of Rheumatology (ACR) criteria or by the presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias).

Exclusion Criteria:

Patients will be excluded if they have:

  • Symptomatic orthostatic hypotension
  • Evidence of current malignancy
  • History of sympathectomy
  • Upper extremity deep vein thrombosis or lymphedema within 3 months
  • Recent surgical procedure requiring general anesthesia
  • AMI, unstable angina, strokes and TIA within the past three months
  • Smoking
  • Use of any investigational drug within 30 days of the study sessions
  • Use of medications that might interfere with tadalafil like nitrates and alpha adrenergic blockers that have vasoactive effects, and patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole, erythromycin, itraconazole, and grapefruit juice
  • Patients taking alcohol
  • Patients with bleeding disorders
  • Significant active peptic ulceration
  • Current pregnancy
  • Current breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626665


Sponsors and Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Investigators
Principal Investigator: Vikas Agarwal, MD, DM Sanjay Gandhi Postgraduate Institute of Medical Sciences

Publications of Results:
Responsible Party: Vikas Agarwal, Additional Professor, Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00626665     History of Changes
Other Study ID Numbers: A-15;PGI/DM/EC/40/7/11/07
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013

Keywords provided by Vikas Agarwal, Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Raynaud disease
Scleroderma

Additional relevant MeSH terms:
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents