Raynaud's PhenomenonPhase 2REINONCT01315899
Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon
A Phase 2 study testing ORM-12471 30mg and ORM-12471 in people with Raynaud's Phenomenon, run by Orion Corporation, Orion Pharma at 1 site in United Kingdom.
Trial summary
Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic impairment of blood flow. During an attack of RP which commonly affects the hands and feet these arteries contract briefly which limits the blood flow (this is called a vasospasm) and deprived of blood the skin turns white then… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Raynaud's Phenomenon
- What is being tested?
- ORM-12471 30mg and ORM-12471
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Dec 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained
- Age of 10-75 years (inclusive)
- Body mass index (BMI) between 10-30 kg/m2 (inclusive)
- Male or female patients with a diagnosis of active Raynaud's phenomenon (RP) secondary to systemic sclerosis. Active RP will be defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as of at least 6 attacks weekly during the winter months. Diagnosis of systemic sclerosis will be defined by the European League Against Rheumatism (EULAR) criteria.
- Stable symptoms for RP and medication requirements within 2 months prior to screening
- Negative pregnancy test for females of childbearing potential
Who cannot join
- Treatment with nitrates
- Treatment with calcium channel blockers (CCBs)for indications other than the relief of RP symptoms
- Treatment with calcium channel blockers (CCBs) for the relief of RP symptoms that in the opinion of the investigator cannot be stopped from the screening visit until end of the last experimental session
- Changes in dosing of other vasoactive medications within 1 month prior to screening or during the study
- Smoking or smoking cessation using nicotine products within 3 months prior to screening
- Current active ischemic digital ulcer and/or tissue gangrene
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- History of sympathectomy
- Upper extremity deep vein thrombosis or lymphoedema within 3 months prior to screening.
- Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, psychiatric or malignant disorder or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study
- Supine Heart rate (HR) >100 beats per minute (bpm) after a 10 minute rest at screening
- Supine systolic BP (SBP)>160 or diastolic BP (DBP)>100 mmmHg after a 10 minute rest at screening visit
- Any other abnormal value of laboratory, vital signs or ECG which may in the opinion of the investigator interfere with the interpretation of the study results or cause a health risk for the subject if he/she takes part into the study.
- Pregnant or breast feeding or considering pregnancy in the next 4 months
- Female subjects of child bearing potential (i.e. menstruating or less than 2 years post menopausal) if they are not using proper contraception (hormonal contraception,intrauterine device [IUD] or surgical sterilisation, spermicidal foam in conjunction with condom on male partner)
- Subjects with pre-planned elective surgery during the estimated study period
- Blood donation or loss of a significant amount of blood within 30 days prior to screening
- Participation in a drug study within 30 days prior to screening
- Known hypersensitivity to the active substance or to any excipients of the drug
- Recent or current (suspected) drug abuse
- Recent or current alcohol abuse (regular drinking more than 14 units per week for females or 21 units per week for males 1 unit= 4cl of spirits or equivalent)
- Inability to refrain from consuming caffeine-containing beverages for at least 12 hours prior to and during treatment visits e.g propensity in getting headache when refraining from caffeine-containing beverages
- Inability to participate in all treatment periods
- Unsuitable veins for repeated venipuncture or for cannulation
- The subject is not able to swallow a test capsule at the screening visit
- Any other condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal NHS foundation Trust
Salford, Greater Manchester, M6 8HD
About this study
Official title: Phase IIa Study of the Efficacy of ORM-12471 for Prevention of Cold-induced Vasospasm: a Randomised, Double-blind, Placebo-controlled, Single Centre Crossover Study in Patients With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic impairment of blood flow. During an attack of RP which commonly affects the hands and feet these arteries contract briefly which limits the blood flow (this is called a vasospasm) and deprived of blood the skin turns white then blue. The aim of this study is to prove the concept that ORM-12741 can prevent these blood vessel spasms.
- Conditions
- Raynaud's Phenomenon
- Being tested
- ORM-12471 30mg, ORM-12471, placebo
- Keywords
- Raynaud's phenomenon, Systemic sclerosis
- Medical subject headings
- Raynaud Disease, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-12471 30mgDrug
Given as a single dose once during the crossover study as per Williams design
ORM-12471Drug
Given as a single dose once during the study as per Williams crossover design
placeboDrug
Given once as a single dose during the study as per Williams crossover design
| Study group | Role | What they receive |
|---|---|---|
| ORM-12471 30mg | Experimental | Not described Receives: Drug: ORM-12471 30mg |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| ORM-12471 100mg | Experimental | Not described Receives: Drug: ORM-12471 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger temperature measurements and laser doppler imaging of the hands
Finger temperature measurements and laser doppler imaging of the hands will be continually monitored from 0 minutes through to 90 minutes.
Measured: 0-90minutes continuous measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Recommendation by study DSMC to the sponsor following interim analysis of 8 subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud's PhenomenonStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariane L Herrick, MB,ChB, MD, Principal investigator, Northern Care Alliance NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315899
- Sponsor's protocol ID
- 3098009
- Acronym
- REINO
- Status last verified
- Jun 2014
- First submitted
- 14 Mar 2011
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herrick AL, Murray AK, Ruck A, Rouru J, Moore TL, Whiteside J, Hakulinen P, Wigley F, Snapir A. A double-blind, randomized, placebo-controlled crossover trial of the alpha2C-adrenoceptor antagonist ORM-12741 for prevention of cold-induced vasospasm in patients with systemic sclerosis. Rheumatology (Oxford). 2014 May;53(5):948-52. doi: 10.1093/rheumatology/ket421. Epub 2014 Jan 31.
PubMed 24489014
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of the Efficacy of ORM-12471 for Prevention of Cold-induced Vasospasm: a Randomised, Double-blind, Placebo-controlled, Single Centre Crossover Study in Patients With Raynaud's Phenomenon Secondary to Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01315899
- Acronym / sponsor ID
- REINO / 3098009
- Conditions
- Raynaud's Phenomenon
- Keywords
- Raynaud's phenomenon, Systemic sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recommendation by study DSMC to the sponsor following interim analysis of 8 subjects.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Mar 2011 (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.
Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic impairment of blood flow. During an attack of RP which commonly affects the hands and feet these arteries contract briefly which limits the blood flow (this is called a vasospasm) and deprived of blood the skin turns white then blue. The aim of this study is to prove the concept that ORM-12741 can prevent these blood vessel spasms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ORM-12471 30mg | Experimental | Drug: ORM-12471 30mg |
| placebo | Placebo comparator | Drug: placebo |
| ORM-12471 100mg | Experimental | Drug: ORM-12471 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained
- Age of 10-75 years (inclusive)
- Body mass index (BMI) between 10-30 kg/m2 (inclusive)
- Male or female patients with a diagnosis of active Raynaud's phenomenon (RP) secondary to systemic sclerosis. Active RP will be defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as of at least 6 attacks weekly during the winter months. Diagnosis of systemic sclerosis will be defined by the European League Against Rheumatism (EULAR) criteria.
- Stable symptoms for RP and medication requirements within 2 months prior to screening
Key exclusion criteria (25 listed)
- Treatment with nitrates
- Treatment with calcium channel blockers (CCBs)for indications other than the relief of RP symptoms
- Treatment with calcium channel blockers (CCBs) for the relief of RP symptoms that in the opinion of the investigator cannot be stopped from the screening visit until end of the last experimental session
- Changes in dosing of other vasoactive medications within 1 month prior to screening or during the study
- Smoking or smoking cessation using nicotine products within 3 months prior to screening
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 |
|---|---|---|
| ORM-12471 30mgGiven as a single dose once during the crossover study as per Williams design | Drug | ORM-12471 30mg |
| ORM-12471Given as a single dose once during the study as per Williams crossover design | Drug | ORM-12471 100mg |
| placeboGiven once as a single dose during the study as per Williams crossover design | Drug | placebo |
Primary outcome
Finger temperature measurements and laser doppler imaging of the hands
Time frame: 0-90minutes continuous measurement
Finger temperature measurements and laser doppler imaging of the hands will be continually monitored from 0 minutes through to 90 minutes.
Results and safety
The study was stopped early (reason given: Recommendation by study DSMC to the sponsor following interim analysis of 8 subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Results publication: PubMed 24489014Herrick AL, Murray AK, Ruck A, Rouru J, Moore TL, Whiteside J, Hakulinen P, Wigley F, Snapir A. A double-blind, randomized, placebo-controlled crossover trial of the alpha2C-adrenoceptor antagonist ORM-12741 for prevention of cold-induced vasospasm in patients with systemic sclerosis. Rheumatology (Oxford). 2014 May;53(5):948-52. doi: 10.1093/rheumatology/ket421. Epub 2014 Jan 31.
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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.
Ariane L Herrick, MB,ChB, MD principal investigator
Northern Care Alliance NHS Foundation Trust
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 ORM-12471 30mg and ORM-12471 in people with Raynaud's Phenomenon, run by Orion Corporation, Orion Pharma at 1 site in United Kingdom.
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 6 inclusion and 25 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 27 Jun 2014. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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: Recommendation by study DSMC to the sponsor following interim analysis of 8 subjects.). 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?
Finger temperature measurements and laser doppler imaging of the hands (time frame: 0-90minutes continuous measurement). 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 NCT01315899, which also lists 1 linked publication.
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 27 Jun 2014.