Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Statins: a potentially useful therapeutic option in the management of systemic sclerosis-related Raynaud's phenomenon and digital ulcers
Acronym
SDURP
Study hypothesis
Systemic Sclerosis (SSc) is a chronic connective tissue disorder characterised by excessive cutaneous and visceral fibrosis, an aberrant immune activation and widespread, pronounced alterations in the microvasculature with structural and functional vasculopathy. Statins have an effect on endothelial dysfunction and thus may help ameliorate Raynaud's phenomenon and digital ulcers characteristic of SSc.
Ethics approval
Ethics approval received from the Ethics Committee of the Faculty of Medicine, University of Alexandria on the 13th of September, 2005.
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Systemic Sclerosis (SSc)
Intervention
The patients are divided into 2 groups:
Group 1: assigned to receive 40 mg/day of atorvastatin for four months
Group 2: assigned to identical placebo tablets for four months
Seventy-five healthy age-sex-matched volunteers serve the purpose of controls.
Intervention type
Drug
Phase
Not Specified
Drug names
Atorvastatin
Primary outcome measure
The primary outcome measure is the number of new digital ulcers occurring during the study period, measured monthly.
Secondary outcome measures
1. The Scleroderma Health Assessment Questionnaire subsets for dressing/grooming (SHAQ-DI)
2. Eating and hand grip
3. Assessment of safety and tolerability of the atorvastatin therapy
All secondary outcomes are measured monthly.
Overall trial start date
30/09/2005
Overall trial end date
05/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Raynaud's phenomenon
2. A history of a documented digital ulcer secondary to SSc within the last 12 months despite ongoing vasodilator therapy
3. Aged between 25 - 60 years, both male and female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Smoking
2. Diabetes mellitus
3. Hypercholesterolaemia
4. Hypertension
5. Cardiac insufficiency
6. Coexisting hepatic and renal diseases and drugs known to interact with statins
Recruitment start date
30/09/2005
Recruitment end date
05/05/2006
Locations
Countries of recruitment
Egypt
Trial participating centre
12 Heliopolis Street
Alexandria
-
Egypt
Sponsor information
Organisation
University of Alexandria (Egypt)
Sponsor details
Faculty of Medicine
12 Heliopolis Street
Camp Cesar
Alexandria
-
Egypt
+20 (0)3 5924035
annaaraya@yahoo.com
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator intiated and funded (Egypt)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18709692
Publication citations
-
Results
Abou-Raya A, Abou-Raya S, Helmii M, Statins: potentially useful in therapy of systemic sclerosis-related Raynaud's phenomenon and digital ulcers., J. Rheumatol., 2008, 35, 9, 1801-1808.