A short-term open-label single site pilot study evaluating the use of asasantin retard therapy in the management of Raynaud’s phenomenon. - Asasantin retard therapy in the management of Raynaud's phenomeno

Phase 1

• Conditions: Primary Raynaud's Phenomenon and Systemic Sclerosis; MedDRA version: 12.1 Level: LLT Classification code 10042953 Term: Systemic Sclerosis; MedDRA version: 12.0 Level: LLT Classification code 10037917 Term: Raynaud's phenomenon

• Registration Number: EUCTR2009-013468-37-GB
• Lead Sponsor: Royal National Hospital for Rheumatic Disease

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Systemic Sclerosis (fulfilling ARA criteria)

or

Primary Raynaud's Phenomenon (defined as at least 2 episodes of fingertip localized notable blue and/or sequential blue and white discoloration, in conjunction with pain upon cold exposure or emotional stress within the one week of examination in the absence of other features of connective tissue disease.

18 to 75 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects shall be excluded from all aspects of the study if:

1) pregnant or breastfeeding (women of child bearing age will be required to practice a medically acceptable method of birth control throughout the study period)

2) surgical sympathectomy performed in the last 12 months

3) Administration of new medications used for the treatment of Raynaud's phenomenon or systemic sclerosis in the 2 months preceding, or during, the trial period.

4) Vasodilators used for the treatment of hypertension must be maintained at a constant dose throughout the study period.

5) Administration of a selective serotonin reuptake inhibitor in the 2 months preceding or during the study period.

6) Refusal by participants for their General Practitioner to be informed of inclusion in the study

Subjects shall remain eligible for the first part of the study but shall be excluded from participation in the second stage of the study if they are:

1) current use of aspirin, dipyridamole or alternative antiplatelet agent

2) primary bleeding diathesis or platelet disorder

3) anticoagulation with warfarin

4) history of peptic or duodenal ulceration

5) history of intolerance or allergy to aspirin, dipyridamole or other nonsteroidal anti-inflammatory medications

6) Current use of oral corticosteroids and/or non-steroidal anti-inflammatory drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified