NCT00528242

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

November 18, 2023

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

September 11, 2007

Last Update Submit

November 14, 2023

Conditions

Raynaud's Disease

Outcome Measures

Primary Outcomes (1)

  • Raynaud's condition scores after 14 days of SLx-2101

    14 days

Secondary Outcomes (1)

  • Safety and tolerability

    14 days

Study Arms (2)

1

EXPERIMENTAL

SLx-2101

Drug: SLx-2101

2

PLACEBO COMPARATOR

Matching Placebo Dose

Drug: Placebo

Interventions

SLx-2101DRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University des Saarlandes

Homburg, Germany

Location

MeSH Terms

Conditions

Raynaud Disease

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • M Baumaker, MD

    University des Saarlandes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

June 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 18, 2023

Record last verified: 2015-01

Locations

DE(1)