DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-006978-15-GB
• Date of registration: 22/05/2009
• Prospective Registration: No
• Primary sponsor: United Therapeutics Corporation
• Public title: DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT
• Scientific title: DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT
• Date of first enrolment: 05/03/2009
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006978-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Canada, United Kingdom, United States

Contacts

• Name: Regulatory Department
• Affiliation: United Therapeutics Europe Ltd

• Name: Regulatory Department
• Affiliation: United Therapeutics Europe Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1) Eligible subjects who completed assessments in the final visit of the previous controlled trials (TDE-DU-201 and TDE-DU-301), and who signed appropriate informed consent, are eligible to enroll in this extension study.
2) If a female of childbearing potential, the subject must agree to continue practicing an acceptable method of birth control (i.e. surgical sterilization, approved hormonal contraceptives, barrier methods [such as a condom or diaphragm] used with a spermicide, or an intrauterine device).
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:
Patients must not:
1) Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
2) Have been found to be unable to complete study assessments in the previous controlled trial;
3) Have prematurely discontinued study drug during the previous study (TDE-DU-201 or TDE-DU-301) due to treatment related adverse events



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Sclerosis, scleroderma digital ulcers
MedDRA version: 14.0 Level: PT Classification code 10039710 Term: Scleroderma System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Product Name: treprostinil diethanolamine
Product Code: UT-15C-SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Product Name: treprostinil diethanolamine
Product Code: UT-15 SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
CAS Number: n/a
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.125-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Adverse events will be reported continuously and clinical laboratory parameters will be assessed at weeks 4, 6, 8/10 and 12

Secondary Objective: 1) Assess the long-term safety of treprostinil diethanolamine SR through assessment of adverse events and laboratory parameters.

2) Assess long-term dosing patterns and the effect, if any, of temporary reduction and re-titration of dosing in subjects.

3) Assess the effect of continued therapy with treprostinil diethanolamine SR on digital ulcers and measures of patient function, SHAQ and CHFS, with long-term treatment.

Main Objective: Provide, or continue to provide, treprostinil diethanolamine SR for eligible subjects who participated in protocols TDE-DU-201 or TDE-DU-301*

* Protocol TDE-DU-301 is planned to be submitted at a future date

Primary end point(s): Adverse events and Clinical Laboratory parameters

Secondary ID(s)

TDE-DU-202