Condition category
Musculoskeletal Diseases
Date applied
05/12/2007
Date assigned
10/12/2007
Last edited
01/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Abou-Raya

ORCID ID

Contact details

12 Heliopolis Street
Camp Cesar
Alexandria
-
Egypt

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 measures

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

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

http://www.alexmed.org

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18709692

Publication citations

  1. 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.

Additional files

Editorial Notes