|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
27 July 2020 |
|
Main ID: |
EUCTR2004-000632-82-GB |
|
Date of registration:
|
11/02/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension
|
|
Scientific title:
|
Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension |
|
Date of first enrolment:
|
16/09/2004 |
|
Target sample size:
|
180 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000632-82 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other:
|
|
Phase:
|
Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
|
|
|
Countries of recruitment
|
|
Italy
|
United Kingdom
| | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Patients who have completed the full study period (24 to 36-week treatment period and 8-week follow up) of the RAPIDS-2 study.
Patients who either present DUs at the end of the RAPIDS-2 study period or develop new DUs thereafter until release of the RAPIDS-2 study results to investigators.
Male or female patients of 18 years of age and older
- Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.
- Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
Signed informed consent
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:
Systolic blood pressure < 85 mmHg.
Hemoglobin concentration < 75% of the lower limit of the normal range
AST and/or ALT values greater than 3 times the upper limit of normal
Pregnancy or breast-feeding
Body weight < 40 kg
Patient who received an investigational product within 1 month preceding screening
Patient with conditions that prevent compliance with the protocol or adhering to therapy
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
Known hypersensitivity to bosentan or any of the excipients
Treatment with any of the following: glibenclamide (glyburide), fluconazole, cyclosporine A, tacrolimus and any other calcineurin inhibitor 1 week prior to bosentan treatment
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease
|
|
Intervention(s)
|
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 147536-97-8
Current Sponsor code: Ro47-0203/029
Concentration unit: % percent
Concentration type: range
Concentration number: 98.0-102.0
|
|
Primary Outcome(s)
|
Primary end point(s): EFFICACY endpoints:
Total number of new DUs per patient observed by the investigator at planned visits (a patient diary will be used to record DUs that might appear and disappear between two planned visits)
Time to complete healing of each baseline DU
Time to complete healing of each new DU
Change from baseline to each assessment carried out every 16 weeks in the Scleroderma Health Assessment Questionnaire (SHAQ) and in the composite of hand components of the SHAQ: grip, hygiene, dressing and grooming
Change from baseline to each assessment carried out every 16 weeks in overall hand pain related to finger ulcers
Change from baseline to each assessment carried out every 16 weeks in UK SSc Functional Score (UKFS)
If appropriate, exploratory endpoints, derived from the clinical database, will be analyzed based on data-driven considerations.
SAFETY/TOLERABILITY endpoints:
Adverse events up to 24 hours after last study medication
Serious adverse events up to 28 days after last study medication
AEs leading to permanent discontinuation of the study medication
|
Main Objective: To collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DU).
|
|
Secondary Objective:
|
|
Secondary ID(s)
|
|
AC-052-333
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 16/09/2004
Contact:
|
|