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Tadalafil for the Treatment of Raynaud's

NCT ID: NCT00822354

Last Updated: 2014-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-04-30

Brief Summary

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The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.

Detailed Description

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The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.

Conditions

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Raynaud

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Subjects will receive tadalafil 20mg every other day for the first month, and then placebo for the second month.

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil

2

Subjects will receive placebo for the first month, and tadalafil 20mg orally every other day for the second month.

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil

Interventions

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Tadalafil

Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil

Intervention Type DRUG

Other Intervention Names

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Cialis

Eligibility Criteria

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Inclusion Criteria

* active Raynaud's Phenomenon
* stable disease and medication requirements over the previous 2 months
* subjects willing and able to participate in study assessments
* ability to understand and sign informed consent
* ages 18 to 65, both sexes
* a diagnosis of diffuse or limited cutaneous sclerosis, MCTD using the American College Rheumatology criteria

Exclusion Criteria

* uncontrolled HTN, DM, unstable disease, angina or using oral nitrates
* smoking, active alcoholism, drug abuse within 5 years
* abnormal renal function
* ulnar arterial occlusive disease as shown by a positive Allen Test
* Pregnant or breast feeding or considering preg. in next 4 months
* past or present major psych. illness
* allergy or sensitivity to tadalafil
* subject unable to understand protocol or give informed consent
* part. in another study trial within 30 days
* taking sildenafil
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Anne Laumann

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Laumann, MBChB, MRCP

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Maltez N, Maxwell LJ, Rirash F, Tanjong Ghogomu E, Harding SE, Tingey PC, Wells GA, Tugwell P, Pope J. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858.CD014089.

Reference Type DERIVED
PMID: 37929840 (View on PubMed)

Other Identifiers

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STU1199

Identifier Type: -

Identifier Source: org_study_id