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Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

Information source: United Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Sclerosis; Scleroderma

Intervention: treprostinil diethanolamine (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: United Therapeutics

Official(s) and/or principal investigator(s):
James Seibold, MD, Principal Investigator, Affiliation: Scleroderma Research Consultants LLC, Avon, CT,

Summary

This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's phenomenon and promote healing of digital ulcers and other ischemic wounds.

Clinical Details

Official title: DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Net Ulcer Burden

Secondary outcome:

Digital Ulcer Pain VAS

Patient Global Assessment of Digital Ulcer Severity VAS

Physician Global Assessment of Digital Ulcer Severity VAS

Cochin Hand Function Scale (CHFS)

Scleroderma Health Assessment Questionnaire (SHAQ)

Modified Rodnan Skin Score (mRSS)

Short-Form McGill Pain Questionnaire

Patient Impression of Change (PIC) Questionnaire

Short Form 36

Time to Ulcer Healing- Percentage of Subjects With Complete Healing

Time to Ulcer Healing

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject gave voluntary written informed consent to participate in the study

- Diagnosis of systemic sclerosis (SSc) as defined by American College of Rheumatology

(ACR) criteria

- Males and females age greater than 18 years at Screening

- Presence of at least one active digital ulcer (met protocol defined qualifications

for active digital ulcer) at Baseline

- Females of childbearing potential willing to use a reliable form of medically

acceptable contraception and have a negative pregnancy test at Screening and Baseline

- Able to communicate effectively with study personnel and willing to comply with

protocol requirements Exclusion Criteria:

- Diagnosis of pulmonary arterial hypertension (PAH)

- Body weight less than 40 kg at Screening and confirmed at Baseline

- History of postural hypotension, unexplained syncope, a blood pressure that is less

than 90 mmHg systolic or 50 mmHg diastolic at Screening and Baseline

- Hemoglobin concentration less than 75% of the lower limit of the normal range at

Screening

- Moderate to severe hepatic impairment, i. e., Child-Pugh Class B or C, or ALT greater

than three times upper limit of normal

- Intractable diarrhea, or severe malabsorption, defined as greater than 15%

unintentional loss of body weight in the last 6 months prior to Screening; any severe organ failure (e. g., lung, kidney), bleeding diathesis or platelet disorder, or any life-threatening condition

- Pregnant or breast-feeding

- Simultaneously fulfilled criteria for a second connective tissue disease including

systemic lupus erythermatosus, rheumatoid arthritis or inflammatory myopathy

- Sympathectomy of the upper limb, involving the hand, performed within 12 months of

Baseline. Sympathectomy performed on the non-target limb (hand not presenting with qualifying ulcers) or which did not include the hand, performed within 6 months of Baseline

- Receipt of prostanoid treatment (epoprostenol, treprostinil sodium, or other

prostacyclin analog) within the previous 3 months of Baseline for conditions including Raynaud's phenomenon, rest pain and / or digital ulcers

- Required systemic antibiotics for infected digital ulcers within 2 weeks of Screening

- Local injection of botulinum toxin in an affected finger within 1 month prior to

Baseline

- Treatment with endothelin receptor antagonists within 1 month prior to Baseline

- Patients on phosphodiasterase inhibitors, such as sildenafil or tadalafil, who have

received treatment for less than 6 months prior to Baseline (unless for intermittent treatment of male erectile dysfunction)

- Treatment with statin within 1 month prior to Screening, unless for management of

hyperlipidemia

- Received an investigational product within 1 month preceding Screening

- Known hypersensitivity to treprostinil diethanolamine or any of the excipients

- Tobacco or nicotine use at any level within the past 6 months prior to Screening

- Any condition or laboratory that in the opinion of the investigator might interfere

with subject's participation, pose an additional risk for the subject, could prevent understanding the objectives, nature or consequences of the trial, compliance with the protocol, adherence to therapy, or that would interfere with interpretation of study assessments

Locations and Contacts

Clinical Sciences Center - University Hospital, Liverpool L9 7AL, United Kingdom

Royal Free Hospital - Center for Rheumatology, London NW32QG, United Kingdom

Salford Royal Hospital, Manchester M139PT, United Kingdom

University of Alabama - Arthritis Clinical Intervention Program, Birmingham, Alabama 35294, United States

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States

UCLA, Los Angeles, California 90095, United States

Stanford University School of Medicine/Palo Alto VA Health Care System, Palo Alto, California 94304, United States

Denver Medical Center, Aurora, Colorado 80045, United States

University of Connecticut Health Center, Farmington, Connecticut 06030, United States

Georgetown University, Washington, District of Columbia 20007, United States

Northwestern University - Feinberg School of Medicine, Chicago, Illinois 60611, United States

University of Indiana School of Medicine, Indianapolis, Indiana 46202, United States

Johns Hopkins University - Division of Rheumatology, Baltimore, Maryland 21224, United States

Boston University School of Medicine, Boston, Massachusetts 02118, United States

University of Michigan Scleroderma Program, Ann Arbor, Michigan 48106, United States

University of Minnesota, Minneapolis, Minnesota 55455, United States

UMDNJ Clinical Research Center, New Brunswick, New Jersey 08903, United States

North Shore-LIJ Health System, Lake Success, New York 11042, United States

The Hospital for Special Surgery, New York, New York 10021, United States

Dalhousie University - QEII Health Science Center, Halifax, Nova Scotia B3H4K4, Canada

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

University of Toledo, Toledo, Ohio 43614, United States

St Joseph's Health Care, London, Ontario N6A4V2, Canada

University of Pittsburgh, Pittsburgh, Pennsylvania 15261, United States

McGill University, Montreal, Quebec H3T1E2, Canada

Medical University of South Carolina, Charleston, South Carolina 29425, United States

University of Texas - Houston, Houston, Texas 77030, United States

University of Utah, Salt Lake City, Utah 84132, United States

Virginia Mason Medical Center, Seattle, Washington 98111, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: May 2009
Last updated: January 31, 2014

Page last updated: August 23, 2015

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