Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease - Full Text View

Sponsor:	Surface Logix
Information provided by:	Surface Logix
ClinicalTrials.gov Identifier:	NCT00528242

Purpose

To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.

Condition	Intervention	Phase
Raynaud's Disease	Drug: SLx-2101	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo-Controlled, Cross-Over Pilot Study to Examine the Safety, Tolerability and Pharmacodynamic Profile of Repeat Oral Doses of SLx-2101 Once Daily for up to 14 Days in Subjects With Secondary Raynaud's Disease.

Resource links provided by NLM:

MedlinePlus related topics: Raynaud's Disease

Further study details as provided by Surface Logix:

Primary Outcome Measures:

Raynaud's condition scores after 14 days of SLx-2101 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment:	17
Study Start Date:	June 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental SLx-2101 vs. placebo	Drug: SLx-2101

Detailed Description:

Number and cumulative duration of Raynaud's attacks.
Adverse events and changes in vital signs.
SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Hypersensitivity to the active substance of SLx-2101or to any of the excipients.
Past or present disease that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528242

Locations

Sponsors and Collaborators

Surface Logix

Investigators

Study Director:

M Baumaker, MD

University des Saarlandes

More Information

No publications provided

Responsible Party:	Surface Logix, Inc. ( Warwick Tong, MB, ChB )
Study ID Numbers:	SLx-2101-07-04
Study First Received:	September 11, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00528242 History of Changes
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:

Cardiovascular Diseases
Raynaud Disease
Vascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010