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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

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

NCT ID

NCT01117298

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

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

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

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

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

ZIP/Postal Code

226014

Country

India

Facility Name

Immunology Rheumatology Unit, IPGMER

City

Kolkatta

State/Province

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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