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

This study has been completed.
Sponsor:
Collaborators:
Institute of Postgraduate Medical Education and Research
Postgraduate Institute of Medical Education and Research
Army Research and Referral hospital
Information provided by:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01117298
First received: May 3, 2010
Last updated: May 7, 2010
Last verified: May 2010

May 3, 2010
May 7, 2010
November 2009
April 2010   (final data collection date for primary outcome measure)
  • Daily frequency, duration and severity of Raynaud's phenomenon [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Appearance or healing of digital ulcers [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Daily frequency, duration and severity of Raynauds phenomenon [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Appearance or healing of digital ulcers [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01117298 on ClinicalTrials.gov Archive Site
  • Improvement in health assessment questionnaire [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Improvement in scleroderma specific health assessment questionnaire [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Improvement in quality of life [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Improvement in biomarkers of endothelial dysfunction [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Improvement in flow mediated dilatation [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study

Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Raynaud's Phenomenon
  • Digital Ulcers
  • Scleroderma
  • Drug: Tadalafil
    Tab Tadalafil, 20 mg alternate day for 8 weeks
    Other Name: Tadalis
  • Drug: Placebo
    Tab Placebo every alternate day for 8 weeks
    Other Name: Placebo
  • Experimental: Tadalafil
    Intervention: Drug: Tadalafil
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Male or female subjects between the ages of 18 years and 65 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma) despite being on vasodilator therapy. Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor. Patients with a history of at least 4 attacks per week during two-week pre-trial period even with treatment with other vasodilators will be recruited. Patients fulfilling the diagnostic criteria of scleroderma (as per American College of Rheumatology criteria) or having presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias)will be invited to participate in the study.

Exclusion Criteria:

Patients with:

  • 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,
  • Acute Myocardial Infarction, unstable angina, strokes and transient ischemic attacks 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01117298
B22:A15:PGI/DM/EC/40/7.11.2007
No
Dr VIkas Agarwal, PI, SGPGIMS
Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • Institute of Postgraduate Medical Education and Research
  • Postgraduate Institute of Medical Education and Research
  • Army Research and Referral hospital
Principal Investigator: Parasar Ghosh, MD, DM IPGMER, Kolkatta
Principal Investigator: Aman Sharma, MD PGIMER, Chandigarh
Principal Investigator: Darshan S Bhakuni, MD Army R&R Hospital, New Delhi
Sanjay Gandhi Postgraduate Institute of Medical Sciences
May 2010

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