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

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ClinicalTrials.gov Identifier: NCT02228850
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Tracking Information
First Submitted Date  ICMJE August 20, 2014
First Posted Date  ICMJE August 29, 2014
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
  • Pharmacodynamic evaluation: digital perfusion by laser Doppler capillary velocimetry and on digital temperature recovery with thermography. [ Time Frame: 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. [ Time Frame: One month ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2014)
  • Pharmacokinetic analysis after topical application: Maximum plasma concentration (Cmax) [ Time Frame: Pre-dose, 5, 15, 30, 60, 90, 120, 240, 360, and 480 minutes post-dose ]
  • Pharmacokinetic analysis after topical application: time to maximum plasma concentration (Tmax) [ Time Frame: Pre-dose, 5, 15, 30, 60, 90, 120, 240, 360, and 480 minutes post-dose ]
  • Pharmacokinetic analysis after topical application: half life (t1/2) [ Time Frame: Pre-dose, 5, 15, 30, 60, 90, 120, 240, 360, and 480 minutes post-dose ]
  • Pharmacokinetic analysis after topical application: area under the plasma concentration time curve (AUC) [ Time Frame: Pre-dose, 5, 15, 30, 60, 90, 120, 240, 360, and 480 minutes post-dose ]
  • Pharmacodynamic evaluation: digital perfusion by laser Doppler capillary velocimetry and on digital temperature recovery by probe and thermography. [ Time Frame: Continuously for two hours after cold challenge ]
  • Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. [ Time Frame: One month ]
Change History Complete list of historical versions of study NCT02228850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Official Title  ICMJE A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)
Brief 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).
Detailed Description The purpose of this study is to evaluate the pharmacodynamic (PD) effects of topical Alprostadil on digital perfusion by laser Doppler capillary velocimetry and digital temperature recovery with thermography following standardized cold challenge and to assess the safety and tolerability of 3 doses of Alprostadil topical cream and placebo cream in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Raynaud's Phenomenon Secondary to Systemic Sclerosis
Intervention  ICMJE
  • Drug: Alprostadil
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Alprostadil Cream (300mcg)
    300 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration
    Interventions:
    • Drug: Alprostadil
    • Other: Placebo
  • Experimental: Alprostadil Cream (1000mcg)
    1000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration
    Interventions:
    • Drug: Alprostadil
    • Other: Placebo
  • Experimental: Alprostadil Cream (3000mcg)
    3000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, two dispensers for each administration
    Interventions:
    • Drug: Alprostadil
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2014)
45
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a diagnosis of SSc by current ACR/EULAR Classification Criteria;
  • Evidence of ongoing activity of Raynaud's Phenomenon as measured by a Raynaud Condition Score of 3 or greater at Screening;
  • All females of childbearing potential must have a negative serum pregnancy test;

    a. Females of childbearing potential must abstain from sexual activity that could result in pregnancy, or agree to use an acceptable method of contraception throughout the study period and for 30 days following dosing of the investigational study drug. Acceptable contraception includes:

    1. Intrauterine devices
    2. Double barrier methods (e.g. condom or diaphragms with spermicidal gel or foam)
    3. Condom use is advised for all forms of contraception
  • Must be willing and able to discontinue ongoing therapy for RP for at least 72 hours prior to each application of study medication; such drugs include calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, short-acting PDE-5i (sildenafil, vardenafil, avanafil), sympatholytics and topical or systemic nitrates;
  • Must be willing and able to discontinue consumption of caffeine-containing products (e.g., beverages and over-the-counter (OTC) medications) for at least 24 hours prior to each day of study dosing;
  • Must be willing and able to remove jewelry from the treated hand prior to each day of study dosing;
  • Must be willing to remove nail polish and/or nail coverings from the treated hand prior to each day of study dosing;
  • Must not donate blood during the study;
  • Have adequate finger extension to permit application of study treatments and attachment of physiologic measuring instruments.
  • Must be willing to comply with all study procedures and study visits;
  • Must provide written informed consent.

Exclusion Criteria:

  • BMI less than 18.5;
  • Clinically significant medical abnormality or history or presence of significant neurological, hepatic, renal, endocrine, gastrointestinal, cardiovascular, pulmonary, psychiatric and/or metabolic condition as determined by the Investigator);
  • Clinical diagnosis of Systemic Sclerosis in association with other rheumatologic diseases including Mixed Connective Tissue Disease;
  • Clinically significant abnormal laboratory test results at screening as determined by the Investigator;
  • Raynaud's Phenomenon thought to be of non-systemic sclerosis etiology;
  • Peripheral or central vasculopathy other than Systemic Sclerosis;
  • History of Scleroderma renal crisis or currently being treated for hypertension, however, subjects with controlled hypertension will not be excluded;
  • Active digital ulcers or rash on hand intended for study medication;
  • History in the past (5) five years of autonomic neuropathy or postural hypotension;
  • Upper extremity sympathectomy at any level in the 12 months prior to study;
  • Tobacco smoking within six months of screening or unwillingness to avoid smoking throughout the study (e.g., cigarette, pipe, cigar, e-cigarettes) and the use of nicotine-containing products;
  • Systolic Blood pressure less than 85mm/Hg;
  • Prostanoid use by any route of administration within the previous six months;
  • Current use of systemic or topical nitrates, endothelin receptor antagonists (e.g., bosentan) or any long-acting PDE-5 Inhibitors (e.g. tadalafil);
  • Use of topical corticosteroid to the hand or fingers within 10 days of screening;
  • Current use of ergot preparations, methysergide, B-adrenergic antagonists, contraceptives containing female steroid hormones, cyclosporine, clonidine, nicotine and cocaine;
  • Pregnant or lactating female;
  • Has known exaggerated pharmacological sensitivity or hypersensitivity to any drug similar to Alprostadil or its excipients;
  • Has known hypersensitivity to nitrile;
  • Involvement in any investigational drug or device study within 30 days prior to screening;
  • History of non-compliance with treatment or clinic visit attendance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02228850
Other Study ID Numbers  ICMJE NexMed 2014-RPS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Study Sponsor  ICMJE NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Barbara Troupin, MD, MBA NEXMED (U.S.A.), Inc.
PRS Account NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Verification Date March 2016

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