DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1

• Conditions: Systemic Sclerosis, scleroderma digital ulcers; MedDRA version: 9.1Level: LLTClassification code 10042953Term: Systemic sclerosis; MedDRA version: 9.1Level: LLTClassification code 10039710Term: Scleroderma

• Registration Number: EUCTR2008-005018-39-GB
• Lead Sponsor: nited Therapeutics Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1) Subject gives voluntary written informed consent to participate in the study.
2) Subject has been diagnosed with systemic sclerosis (SSc) as defined by American College of Rheumatology (ACR) criteria.
3) Males and females age greater than 18 years at time of Screening.
4)Presence of at least one active digital ulcer (meets protocol defined qualifications for active digital ulcer, Section 3.3.1.1) at Baseline.
5) Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test at Screening and confirmed at Baseline. Women who are surgically sterile or have been post-menopausal for at least 2 years are not considered to be of child-bearing potential.
6) Subject is able to communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Has diagnosis of pulmonary arterial hypertension (PAH).
2)Body weight less than 40 kg at time of Screening, confirmed at Baseline.
3)The subject has a history of postural hypotension, unexplained syncope, a blood pressure that is less than 95 mmHg systolic or 50 mmHg diastolic at Screening or Baseline.
4)Hemoglobin concentration less than 75% of the lower limit of the normal range at time of Screening.
5)Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
6)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.
7)Pregnancy or breast-feeding.
8) Simultaneously fulfills criteria for a second connective tissue disease including systemic lupus erythematosus, rheumatoid arthritis, or inflammatory myopathy
9)Sympathectomy of the upper limb performed within 12 months of Baseline.
10)Receipt of prostanoid treatment (epoprostenol, treprostinil sodium, or other prostacyclin analog) within the previous 3 months of Baseline for conditions including Reynaud’s phenomenon, rest pain and / or digital ulcers.
11)Patients who have required systemic antibiotics for infected digital ulcers within 2 weeks of Screening.
12)Local injection of botulinum toxin in an affected finger within 1 month prior to Baseline.
13)Treatment with endothelin receptor antagonists within 1 month prior to Baseline.
14)Treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction.
15)Treatment with statin within 1 month prior to Screening, unless for management of hyperlipidemia.
16)Received an investigational product within 1 month preceding Screening.
17)Known hypersensitivity to treprostinil diethanolamine or any of the excipients.
18)Tobacco or nicotine use at any level within the past 6 months prior to Screening.
19)Any condition or laboratory value that in the opinion of the investigator might interfere with the subject's participation in the study, poses an added 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 the interpretation of study assessments.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified