Systemic SclerosisPhase 2ILODOSENCT00622687
Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis
A Phase 2 study testing iloprost, iloprost low dose and iloprost therapy up to 2 ng/kg x min in people with Systemic Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- iloprost, iloprost low dose and iloprost therapy up to 2 ng/kg x min
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 1997to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course
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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- iloprost, iloprost low dose, iloprost therapy up to 2 ng/kg x min
- Keywords
- iloprost, systemic sclerosis, digital ulcers, observational study, randomized
- Medical subject headings
- Scleroderma, Systemic, digital ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloprostDrug
Also called intravenous ilomedin
0.5-2 ng/kg x min for 6hours a day for 21 consecutive days
iloprost low doseDrug
Also called intravenous ilomedin
0.5 ng/kg x min over 6 h per day for 21 consecutive days
iloprost therapy up to 2 ng/kg x minDrug
Also called ilomedin treatment
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
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | low dose iloprost therapy 0.5 ng/kg x min Receives: Drug: iloprost low dose; Drug: iloprost therapy up to 2 ng/kg x min |
| B | Active comparator | high-dose therapy Receives: Drug: iloprost; Drug: iloprost therapy up to 2 ng/kg x min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of digital ulcers
Measured: 5 weeks
Secondary outcomes (7)
Duration of RP
Measured: 6 weeks
Frequency of RP
Measured: 6 weeks
changes in lung function
Measured: 4 years
changes in MRSS
Measured: 6 years
subjective improvement of esophagus function
Measured: 1 year
subjective benefit from iloprost therapy
Measured: 1 year
side effecs
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startSep 1997
- Primary completionDec 2003
- Study completionDec 2007
Why it stopped: sufficient number to reach the primary endpoint and as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Gabriela Riemekasten, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622687
- Sponsor's protocol ID
- ILO-1998
- Other IDs
- Schering GmbH
- Acronym
- ILODOSE
- Status last verified
- Dec 2007
- First submitted
- 14 Feb 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9627952Kawald 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.
PubMed 18634152
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course
- ClinicalTrials.gov ID
- NCT00622687
- Acronym / sponsor ID
- ILODOSE / ILO-1998
- Conditions
- Systemic Sclerosis
- Keywords
- iloprost, systemic sclerosis, digital ulcers, observational study, randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sufficient number to reach the primary endpoint and as planned
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Sep 1997
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: iloprost low dose, Drug: iloprost therapy up to 2 ng/kg x minlow dose iloprost therapy 0.5 ng/kg x min |
| B | Active comparator | Drug: iloprost, Drug: iloprost therapy up to 2 ng/kg x minhigh-dose therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iloprostAlso: intravenous ilomedin0.5-2 ng/kg x min for 6hours a day for 21 consecutive days | Drug | B |
| iloprost low doseAlso: intravenous ilomedin0.5 ng/kg x min over 6 h per day for 21 consecutive days | Drug | A |
| iloprost therapy up to 2 ng/kg x minAlso: ilomedin treatmentstarting 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 | Drug | A, B |
Primary outcome
Healing of digital ulcers
Time frame: 5 weeks
7 secondary outcomes
Duration of RP
Time frame: 6 weeks
Frequency of RP
Time frame: 6 weeks
changes in lung function
Time frame: 4 years
changes in MRSS
Time frame: 6 years
subjective improvement of esophagus function
Time frame: 1 year
subjective benefit from iloprost therapy
Time frame: 1 year
side effecs
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: sufficient number to reach the primary endpoint and as planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
- Background: PubMed 9627952Riemekasten 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.
- Derived from this study: PubMed 18634152Kawald 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Riemekasten, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iloprost, iloprost low dose and iloprost therapy up to 2 ng/kg x min in people with Systemic Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: sufficient number to reach the primary endpoint and as planned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of digital ulcers (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2008.