Bosentan in Systemic Sclerosis (HOME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01395732|
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : January 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Digital Ulcers||Drug: Bosentan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.
- Mean blood flow restriction in patients [ Time Frame: Baseline to 12 weeks ]Relationship between blood flow in the hands, as measured by laser Doppler imaging, and extent of Digital Ulcer disease assessed by the mean blood flow restriction in four distinct groups of patients: patients without current Digital Ulcers (pitting scars allowed), patients with new Digital Ulcers (< 3 months), patients with persistent Digital Ulcers (> 3 months) and patients with significant tip-necrosis.
- Change in blood flow in the hands [ Time Frame: Baseline to 12 weeks of bosentan treatment ]Change in blood flow in the hands after 12 weeks of bosentan treatment compared to the baseline, as measured by laser Doppler imaging.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395732
|Amsterdam, Netherlands, 10811HV|
|Groningen, Netherlands, 9700RB|
|Leeuwarden, Netherlands, 8934AD|
|Leiden, Netherlands, 2333ZA|
|Maastricht, Netherlands, 6229HX|
|UMC St Radboud|
|Nijmegen, Netherlands, 6525GA|
|Rotterdam, Netherlands, 3015CE|
|Sint Franciscus Gasthuis|
|Rotterdam, Netherlands, 3045PM|
|Rotterdam, Netherlands, 3078HT|
|Zwolle, Netherlands, 8011JW|