CompletedPhase 2

Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

United States35 participantsStarted 2014-11

Plain-language 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).

Who can participate

Age range18 Years – 79 Years

SexALL

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Inclusion criteria

✓. Intrauterine devices
✓. Double barrier methods (e.g. condom or diaphragms with spermicidal gel or foam)
✓. Condom use is advised for all forms of contraception

What they're measuring

Pharmacodynamic evaluation: digital perfusion by laser Doppler capillary velocimetry and on digital temperature recovery with thermography.

Timeframe: two hours (intermittently) after cold-challenge and post-dose

Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Timeframe: One month

Trial details

NCT IDNCT02228850

SponsorNexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

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