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

Primary Purpose

Raynaud's Phenomenon, Digital Ulcers, Scleroderma

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Tadalafil
Placebo
Sponsored by
Sanjay Gandhi Postgraduate Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud's Phenomenon focused on measuring Raynaud's phenomenon, ischemic ulcers, digital ulcers, digital infarcts, gangrene, vasodilators, endothelial dysfunction, scleroderma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Clinical Immunology, Army R&R hospital
  • Medicine Unit II, PGIMER
  • Department of Immunology, SGPGIMS
  • Immunology Rheumatology Unit, IPGMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tadalafil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Daily frequency, duration and severity of Raynaud's phenomenon
Appearance or healing of digital ulcers

Secondary Outcome Measures

Improvement in health assessment questionnaire
Improvement in scleroderma specific health assessment questionnaire
Improvement in quality of life
Improvement in biomarkers of endothelial dysfunction
Improvement in flow mediated dilatation

Full Information

First Posted
May 3, 2010
Last Updated
May 7, 2010
Sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Collaborators
Institute of Postgraduate Medical Education and Research, Postgraduate Institute of Medical Education and Research, Army Research and Referral hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01117298
Brief Title
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Collaborators
Institute of Postgraduate Medical Education and Research, Postgraduate Institute of Medical Education and Research, Army Research and Referral hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Phenomenon, Digital Ulcers, Scleroderma
Keywords
Raynaud's phenomenon, ischemic ulcers, digital ulcers, digital infarcts, gangrene, vasodilators, endothelial dysfunction, scleroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tadalafil
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Other Intervention Name(s)
Tadalis
Intervention Description
Tab Tadalafil, 20 mg alternate day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tab Placebo every alternate day for 8 weeks
Primary Outcome Measure Information:
Title
Daily frequency, duration and severity of Raynaud's phenomenon
Time Frame
Baseline and 8 weeks
Title
Appearance or healing of digital ulcers
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Improvement in health assessment questionnaire
Time Frame
Baseline and 8 weeks
Title
Improvement in scleroderma specific health assessment questionnaire
Time Frame
Baseline and 8 weeks
Title
Improvement in quality of life
Time Frame
Baseline and 8 weeks
Title
Improvement in biomarkers of endothelial dysfunction
Time Frame
Baseline and 8 weeks
Title
Improvement in flow mediated dilatation
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parasar Ghosh, MD, DM
Organizational Affiliation
IPGMER, Kolkatta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aman Sharma, MD
Organizational Affiliation
PGIMER, Chandigarh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darshan S Bhakuni, MD
Organizational Affiliation
Army R&R Hospital, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Immunology, Army R&R hospital
City
New Delhi
State/Province
ND
Country
India
Facility Name
Medicine Unit II, PGIMER
City
Chandigarh
State/Province
Punjab
Country
India
Facility Name
Department of Immunology, SGPGIMS
City
Lucknow
State/Province
UP
ZIP/Postal Code
226014
Country
India
Facility Name
Immunology Rheumatology Unit, IPGMER
City
Kolkatta
State/Province
WB
Country
India

12. IPD Sharing Statement

Links:
URL
http://www.medscape.com/viewarticle/582592
Description
Related Info

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

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