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Bosentan in Digital Ulcers (RAPIDS 2 OL)

Primary Purpose

Digital Ulcers

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bosentan 62.5 mg
Bosentan 125 mg
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digital Ulcers focused on measuring digital ulcers, systemic sclerosis, finger ulcers, bosentan, open label

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with SSc according to the classification criteria of the American College of Rheumatology SSc patients with at least one DU at baseline qualifying as a CU (see definition section 3.2.2) CU occurred < 3 months and > 1 week prior to randomization. The subset of patients with SSc felt to be at high risk for DUs will be identified in the screening period but will not be eligible for enrollment until a CU has developed Male or female patients >/= 18 years of age 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. Exclusion Criteria: DUs due to condition other than SSc Severe PAH (WHO class III and IV) 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 Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C Severe malabsorption or any severe organ failure (e.g., lung, kidney) or any life-threatening condition Pregnancy or breast-feeding Previous treatment with bosentan Treatment with any of the following: glibenclamide (glyburide), fluconazole, cyclosporine A, tacrolimus and any other calcineurin inhibitor 1 week prior to randomization Local injection of botulinum toxin in an affected finger 1 month prior to randomization Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, treprostinil sodium or other prostacyclin analogs) 3 months prior to randomization Treatment with inhaled or oral prostanoids one month prior to randomization Systemic antibiotics to treat infection of DUs 2 weeks prior to randomization Treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction Body weight < 40 kg Patient with conditions that prevent compliance with the protocol or adhering to therapy Patient who received an investigational product within 1 month preceding screening Known hypersensitivity to bosentan or any of the excipients.

Sites / Locations

  • Barri Fessler, MD
  • Daniel Furst, MD
  • David Collier, MD
  • Naomi Rothfield, MD
  • Nadera Sweiss, MD
  • Mittie Doyle, MD
  • Frederick Wigley, MD
  • Peter Merkel, MD
  • Thomas Osborn, MD
  • Vivien Hsu, MD - UMDNJ
  • Avram Goldberg, MD
  • Bashar Kahaleh, MD
  • Thomas Medsger, MD
  • Edwin Smith, MD
  • Medical Universtiy of South Carolina
  • Maureen Mayes, MD
  • Jerry Molitor, MD
  • Howard Kenney, MD
  • Mary Ellen Csuka, MD
  • Universitatsklinik
  • AKH Universitatsklinik
  • Janet Pope, MD
  • Peter Lee, MD
  • Eric Rich, MD
  • Murray Baron, MD
  • Centre Hospitalier Universitaire
  • CHRU Claude Huriez
  • Universitatsklinikum
  • Universitatsklinikum
  • Universitatsklinik
  • Universitatsklinik
  • Instituto di Clinica, Villa Monna Tessa
  • Ospedale Maggiore
  • Policlinico Umberto 1
  • Inselspital, Universitatspital Bern
  • Selly Oak Hospital
  • Royal Free Hospital
  • Freeman Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bosentan

Arm Description

Bosentan 62.5 mg tablets b.i.d. for the first 4 weeks followed by bosentan 125 mg b.i.d. thereafter

Outcomes

Primary Outcome Measures

Time to Complete Healing of Each Baseline DU
Time to Complete Healing of Each New DU
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers
Overall hand pain related to finger ulcers was assessed by the patient using a Visual Analogue Scale. Patients were instructed to score their pain by marking on the continuous 10-cm scale, where 0 (left) was no pain and 100 (right) very severe pain, in response to the question, "How much pain have you had because of your finger ulcers in the past week?" The investigator measured the distance in millimeters between 0 and the patient mark with the ruler provided and recorded the distance.
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS)
UKFS relates to upper and lower extremity function and muscle weakness. For each item, the patient indicated the responses that best described their current ability: "able to perform in a normal manner," "able to perform with alteration in style," "can only manage with difficulty," and "impossible to achieve." Each response was given an integer from 0 (able to perform in a normal manner) to 3 (impossible to achieve), and the sum of individual responses provided an overall score of 0 to 33. Missing values were replaced with the worst value the patient reported on the other items at that visit.
Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits
The total number of new DUs per patient observed by the investigator at planned visits and new transient DUs recorded in the patient diary (a patient diary was used to record DUs that might appear and disappear between two planned visits) were assessed at each clinic visit

Secondary Outcome Measures

Adverse Events up to 24 Hours After Last Study Medication
Number of patients with at least one treatment-emergent adverse event. All adverse events that occurred after study drug initiation and up to 24 hours after study drug discontinuation were to be recorded.
Adverse Events Leading to Permanent Discontinuation of the Study Medication
Number of patients with an adverse event leading to permanent discontinuation of the study treatment
Serious Adverse Events up to 28 Days After Last Study Medication
Number of patients with at least one treatment-emergent serious adverse event (TESAE) were reported. TESAEs are serious AEs that occurred after study drug initiation and up to 28 days after study drug discontinuation. More details on the SAEs are provided in the specific Adverse Events Section

Full Information

First Posted
April 27, 2006
Last Updated
December 18, 2018
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00319696
Brief Title
Bosentan in Digital Ulcers
Acronym
RAPIDS 2 OL
Official Title
Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 8, 2004 (Actual)
Primary Completion Date
January 22, 2009 (Actual)
Study Completion Date
January 22, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digital Ulcers
Keywords
digital ulcers, systemic sclerosis, finger ulcers, bosentan, open label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bosentan
Arm Type
Experimental
Arm Description
Bosentan 62.5 mg tablets b.i.d. for the first 4 weeks followed by bosentan 125 mg b.i.d. thereafter
Intervention Type
Drug
Intervention Name(s)
Bosentan 62.5 mg
Intervention Description
Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose)
Intervention Type
Drug
Intervention Name(s)
Bosentan 125 mg
Intervention Description
Bosentan 125-mg oral tablets administered b.i.d. (target dose)
Primary Outcome Measure Information:
Title
Time to Complete Healing of Each Baseline DU
Time Frame
Baseline to healing
Title
Time to Complete Healing of Each New DU
Time Frame
New DU occurence to healing
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity
Description
SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: "without any difficulty", "with some difficulty," "with much difficulty," or "unable to do," equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Time Frame
80 weeks
Title
Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers
Description
Overall hand pain related to finger ulcers was assessed by the patient using a Visual Analogue Scale. Patients were instructed to score their pain by marking on the continuous 10-cm scale, where 0 (left) was no pain and 100 (right) very severe pain, in response to the question, "How much pain have you had because of your finger ulcers in the past week?" The investigator measured the distance in millimeters between 0 and the patient mark with the ruler provided and recorded the distance.
Time Frame
80 weeks
Title
Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS)
Description
UKFS relates to upper and lower extremity function and muscle weakness. For each item, the patient indicated the responses that best described their current ability: "able to perform in a normal manner," "able to perform with alteration in style," "can only manage with difficulty," and "impossible to achieve." Each response was given an integer from 0 (able to perform in a normal manner) to 3 (impossible to achieve), and the sum of individual responses provided an overall score of 0 to 33. Missing values were replaced with the worst value the patient reported on the other items at that visit.
Time Frame
80 weeks
Title
Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits
Description
The total number of new DUs per patient observed by the investigator at planned visits and new transient DUs recorded in the patient diary (a patient diary was used to record DUs that might appear and disappear between two planned visits) were assessed at each clinic visit
Time Frame
At planned visits up to week 80
Secondary Outcome Measure Information:
Title
Adverse Events up to 24 Hours After Last Study Medication
Description
Number of patients with at least one treatment-emergent adverse event. All adverse events that occurred after study drug initiation and up to 24 hours after study drug discontinuation were to be recorded.
Time Frame
80 weeks
Title
Adverse Events Leading to Permanent Discontinuation of the Study Medication
Description
Number of patients with an adverse event leading to permanent discontinuation of the study treatment
Time Frame
80 weeks
Title
Serious Adverse Events up to 28 Days After Last Study Medication
Description
Number of patients with at least one treatment-emergent serious adverse event (TESAE) were reported. TESAEs are serious AEs that occurred after study drug initiation and up to 28 days after study drug discontinuation. More details on the SAEs are provided in the specific Adverse Events Section
Time Frame
80 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with SSc according to the classification criteria of the American College of Rheumatology SSc patients with at least one DU at baseline qualifying as a CU (see definition section 3.2.2) CU occurred < 3 months and > 1 week prior to randomization. The subset of patients with SSc felt to be at high risk for DUs will be identified in the screening period but will not be eligible for enrollment until a CU has developed Male or female patients >/= 18 years of age 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. Exclusion Criteria: DUs due to condition other than SSc Severe PAH (WHO class III and IV) 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 Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C Severe malabsorption or any severe organ failure (e.g., lung, kidney) or any life-threatening condition Pregnancy or breast-feeding Previous treatment with bosentan Treatment with any of the following: glibenclamide (glyburide), fluconazole, cyclosporine A, tacrolimus and any other calcineurin inhibitor 1 week prior to randomization Local injection of botulinum toxin in an affected finger 1 month prior to randomization Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, treprostinil sodium or other prostacyclin analogs) 3 months prior to randomization Treatment with inhaled or oral prostanoids one month prior to randomization Systemic antibiotics to treat infection of DUs 2 weeks prior to randomization Treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction Body weight < 40 kg Patient with conditions that prevent compliance with the protocol or adhering to therapy Patient who received an investigational product within 1 month preceding screening Known hypersensitivity to bosentan or any of the excipients.
Facility Information:
Facility Name
Barri Fessler, MD
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-7201
Country
United States
Facility Name
Daniel Furst, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1670
Country
United States
Facility Name
David Collier, MD
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Naomi Rothfield, MD
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1310
Country
United States
Facility Name
Nadera Sweiss, MD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Mittie Doyle, MD
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Frederick Wigley, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Peter Merkel, MD
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2394
Country
United States
Facility Name
Thomas Osborn, MD
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Vivien Hsu, MD - UMDNJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Avram Goldberg, MD
City
Manhasset
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Bashar Kahaleh, MD
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Thomas Medsger, MD
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Edwin Smith, MD
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical Universtiy of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Maureen Mayes, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Jerry Molitor, MD
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Howard Kenney, MD
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Mary Ellen Csuka, MD
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Universitatsklinik
City
Innsbruck
Country
Austria
Facility Name
AKH Universitatsklinik
City
Wien
Country
Austria
Facility Name
Janet Pope, MD
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Peter Lee, MD
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Eric Rich, MD
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Murray Baron, MD
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
Centre Hospitalier Universitaire
City
Grenoble
Country
France
Facility Name
CHRU Claude Huriez
City
Lille
Country
France
Facility Name
Universitatsklinikum
City
Dresden
Country
Germany
Facility Name
Universitatsklinikum
City
Erlangen
Country
Germany
Facility Name
Universitatsklinik
City
Freiburg
Country
Germany
Facility Name
Universitatsklinik
City
Koln
Country
Germany
Facility Name
Instituto di Clinica, Villa Monna Tessa
City
Firenze
Country
Italy
Facility Name
Ospedale Maggiore
City
Milano
Country
Italy
Facility Name
Policlinico Umberto 1
City
Roma
Country
Italy
Facility Name
Inselspital, Universitatspital Bern
City
Bern
Country
Switzerland
Facility Name
Selly Oak Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Bosentan in Digital Ulcers

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