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
  Purpose

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.


Condition Intervention Phase
Raynaud's Phenomenon
Digital Ulcers
Scleroderma
Drug: Tadalafil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study

Resource links provided by NLM:


Further study details as provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tadalafil Drug: Tadalafil
Tab Tadalafil, 20 mg alternate day for 8 weeks
Other Name: Tadalis
Placebo Comparator: Placebo Drug: Placebo
Tab Placebo every alternate day for 8 weeks
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117298

Locations
India
Department of Clinical Immunology, Army R&R hospital
New Delhi, ND, India
Medicine Unit II, PGIMER
Chandigarh, Punjab, India
Department of Immunology, SGPGIMS
Lucknow, UP, India, 226014
Immunology Rheumatology Unit, IPGMER
Kolkatta, WB, India
Sponsors and Collaborators
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
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr VIkas Agarwal, PI, SGPGIMS
ClinicalTrials.gov Identifier: NCT01117298     History of Changes
Other Study ID Numbers: B22:A15:PGI/DM/EC/40/7.11.2007
Study First Received: May 3, 2010
Last Updated: May 7, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Raynaud's phenomenon
ischemic ulcers
digital ulcers
digital infarcts
gangrene
vasodilators
endothelial dysfunction
scleroderma

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

ClinicalTrials.gov processed this record on October 19, 2014