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Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis (ILODOSE)

Primary Purpose

Systemic Sclerosis

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

iloprost

iloprost low dose

iloprost therapy up to 2 ng/kg x min

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring iloprost, systemic sclerosis, digital ulcers, observational study, randomized

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with secondary Raynaud's phenomenon suffering from severe Raynaud-'s phenomenon with trophical changes or from digital ulcers with written informed consent. Patients had to be stable for their systemic disease and were on stable medication concerning immunosuppression or vasoactive therapies for three months.

Exclusion Criteria:

Current smokers, patients with a history of gastric ulcers in the last three months, a cardiac ejection fraction below 25%, patients with severe organ involvement or other uncontrolled diseases such as instable angina pectoris, severe anaemia, coagulopathies, azothaemia, cerebral stroke in the last 6 months or malignant diseases were excluded from the study. The last iloprost therapy had to be finished at least 6 months ago. Participation in other studies during the last 4 weeks was also not allowed. For fertile women, a negative pregnancy test was required.

Sites / Locations

Charrité Universitätsmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

low dose iloprost therapy 0.5 ng/kg x min

high-dose therapy

Outcomes

Primary Outcome Measures

Healing of digital ulcers

Secondary Outcome Measures

Duration of RP

Frequency of RP

changes in lung function

changes in MRSS

subjective improvement of esophagus function

subjective benefit from iloprost therapy

side effecs

Full Information

NCT ID

NCT00622687

First Posted

February 14, 2008

Last Updated

February 22, 2008

Sponsor

Charite University, Berlin, Germany

Collaborators

Schering-Plough

1. Study Identification

Unique Protocol Identification Number

NCT00622687

Brief Title

Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis

Acronym

ILODOSE

Official Title

Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Terminated

Why Stopped

sufficient number to reach the primary endpoint and as planned

Study Start Date

September 1997 (undefined)

Primary Completion Date

December 2003 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Schering-Plough

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study compared the efficacy of different dosages of long-term iloprost treatment on Raynaud's phenomenon, ulcer healing, skin thickening, and progression of internal organ sclerosis in systemic sclerosis (SSc). Methods. 50 SSc patients were 1:1 randomised either for maximally tolerated dose up to 2 ng/kg body weight [bw] per minute or low dose (0.5 ng/kg bw per minute) intravenous iloprost administration, for six hours daily over 21 days. The effect on RP, ulcer healing, skin thickness, oesophagus function, lung involvement as assessed by lung function parameters FVC and DLCO, and side effects were measured. Conclusions. The efficacy of prolonged administration of iloprost is also achieved with low dose iloprost by long term treatment. The effects suggest a disease-modifying capability of iloprost, but further studies are needed to proof this hypothesis.

Detailed Description

50 SSc patients (23 patients with limited SSc; 15 patients with diffuse SSc, and 12 patients with overlap syndromes fulfilling the ACR criteria for systemic sclerosis) and suffering from severe Raynaud's phenomenon were included into the study after written informed consent to participate in this study. Severe Raynaud's phenomenon was defined by a high burden of disease, by trophic skin changes, or the presence of digital ulcers. Patients suffering from SSc related RP and/or digital ulceration were randomized 1 : 1 to one of the following groups that received either high or low dose infusions of iloprost for 21 consecutive days given once or twice a year. High dose patients (n=25) started on 0.5ng per kg bw and min over 6 hours a day. Depending on the tolerability the dosages were increased in increments gradually every two days for 0.5 ng/kg x min. The maximum dose administered was 2.0ng/kg bw and min. Low dose patients (n=25) were permanently treated with 0.5ng/kg bw over 6 hours per day for 21 consecutive days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Sclerosis

Keywords

iloprost, systemic sclerosis, digital ulcers, observational study, randomized

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

low dose iloprost therapy 0.5 ng/kg x min

Arm Title

Arm Type

Active Comparator

Arm Description

high-dose therapy

Intervention Type

Drug

Intervention Name(s)

iloprost

Other Intervention Name(s)

intravenous ilomedin

Intervention Description

0.5-2 ng/kg x min for 6hours a day for 21 consecutive days

Intervention Type

Drug

Intervention Name(s)

iloprost low dose

Other Intervention Name(s)

intravenous ilomedin

Intervention Description

0.5 ng/kg x min over 6 h per day for 21 consecutive days

Intervention Type

Drug

Intervention Name(s)

iloprost therapy up to 2 ng/kg x min

Other Intervention Name(s)

ilomedin treatment

Intervention Description

starting therapy at doses of 0.5 ng/kg x min, increase the dose every two days for 0.5 ng/kg x min up to the maximally tolerated dose or to 2 ng/kg x min

Primary Outcome Measure Information:

Title

Healing of digital ulcers

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

Duration of RP

Time Frame

6 weeks

Title

Frequency of RP

Time Frame

6 weeks

Title

changes in lung function

Time Frame

4 years

Title

changes in MRSS

Time Frame

6 years

Title

subjective improvement of esophagus function

Time Frame

1 year

Title

subjective benefit from iloprost therapy

Time Frame

1 year

Title

side effecs

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with secondary Raynaud's phenomenon suffering from severe Raynaud-'s phenomenon with trophical changes or from digital ulcers with written informed consent. Patients had to be stable for their systemic disease and were on stable medication concerning immunosuppression or vasoactive therapies for three months. Exclusion Criteria: Current smokers, patients with a history of gastric ulcers in the last three months, a cardiac ejection fraction below 25%, patients with severe organ involvement or other uncontrolled diseases such as instable angina pectoris, severe anaemia, coagulopathies, azothaemia, cerebral stroke in the last 6 months or malignant diseases were excluded from the study. The last iloprost therapy had to be finished at least 6 months ago. Participation in other studies during the last 4 weeks was also not allowed. For fertile women, a negative pregnancy test was required.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriela Riemekasten, MD

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charrité Universitätsmedizin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

9627952

Citation

Riemekasten G, Jepsen H, Burmester GR, Hiepe F. [Iloprost administration over 21 days as an effective therapy in systemic scleroderma--case report and review of the literature]. Z Rheumatol. 1998 Apr;57(2):118-24. doi: 10.1007/s003930050070. German.

Results Reference

background

PubMed Identifier

18634152

Citation

Kawald A, Burmester GR, Huscher D, Sunderkotter C, Riemekasten G. Low versus high-dose iloprost therapy over 21 days in patients with secondary Raynaud's phenomenon and systemic sclerosis: a randomized, open, single-center study. J Rheumatol. 2008 Sep;35(9):1830-7. Epub 2008 Jul 15.

Results Reference

derived

Links:

URL

http://www.charite.de

Description

Related Info

URL

http://www.Sklerodermie.info

Description

Related Info

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Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis

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