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

Tracking Information

First Received Date ^ICMJE

September 11, 2007

Last Updated Date

December 17, 2008

Start Date ^ICMJE

June 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00528242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease

Official Title ^ICMJE

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.

Brief Summary

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Raynaud's Disease

Intervention ^ICMJE

Drug: SLx-2101

Study Arms / Comparison Groups

Experimental: SLx-2101 vs. placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

male and female ages 18 and 65 y.o.
BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive).

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00528242

Responsible Party

Warwick Tong, MB, ChB, Surface Logix, Inc.

Study ID Numbers ^ICMJE

SLx-2101-07-04

Study Sponsor ^ICMJE

Surface Logix

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

M Baumaker, MD

University des Saarlandes

Information Provided By

Surface Logix

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP