NCT00622687

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
Last Updated

February 25, 2008

Status Verified

December 1, 2007

Enrollment Period

6.3 years

First QC Date

February 14, 2008

Last Update Submit

February 22, 2008

Conditions

Systemic Sclerosis

Keywords

iloprostsystemic sclerosisdigital ulcersobservational studyrandomized

Outcome Measures

Primary Outcomes (1)

  • Healing of digital ulcers

    5 weeks

Secondary Outcomes (7)

  • Duration of RP

    6 weeks

  • Frequency of RP

    6 weeks

  • changes in lung function

    4 years

  • changes in MRSS

    6 years

  • subjective improvement of esophagus function

    1 year

  • +2 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

low dose iloprost therapy 0.5 ng/kg x min

Drug: iloprost low doseDrug: iloprost therapy up to 2 ng/kg x min

B

ACTIVE COMPARATOR

high-dose therapy

Drug: iloprostDrug: iloprost therapy up to 2 ng/kg x min

Interventions

iloprostDRUG

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

Also known as: intravenous ilomedin
B
iloprost low doseDRUG

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

Also known as: intravenous ilomedin
A
iloprost therapy up to 2 ng/kg x minDRUG

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

Also known as: ilomedin treatment
AB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charrité Universitätsmedizin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (2)

  • 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.

    PMID: 9627952BACKGROUND

  • 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.

    PMID: 18634152DERIVED

Related Links

MeSH Terms

Conditions

Scleroderma, Systemicdigital ulcers

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Gabriela Riemekasten, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

September 1, 1997

Primary Completion

December 1, 2003

Study Completion

December 1, 2007

Last Updated

February 25, 2008

Record last verified: 2007-12

Locations

DE(1)