Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
This study has been completed.
Information provided by:
First received: September 11, 2007
Last updated: December 17, 2008
Last verified: September 2007
To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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:
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 ]
|Study Start Date:||June 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- 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
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