Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
NCT02228850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2016-03-22
Summary
The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
Conditions
- Raynaud's Phenomenon Secondary to Systemic Sclerosis
Interventions
- DRUG
-
Alprostadil
- OTHER
-
Placebo
Sponsors & Collaborators
-
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
lead INDUSTRY
Principal Investigators
-
Barbara Troupin, MD, MBA · NEXMED (U.S.A.), Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2015-06-30
- Completion
- 2015-12-31
Countries
- United States
Study Locations
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