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Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon (REINO)

Primary Purpose

Raynaud's Phenomenon

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
ORM-12471 30mg
ORM-12471
placebo
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Raynaud's Phenomenon focused on measuring Raynaud's phenomenon, Systemic sclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Salford Royal NHS foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

ORM-12471 30mg

placebo

ORM-12471 100mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2011
Last Updated
June 26, 2014
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01315899
Brief Title
Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon
Acronym
REINO
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Recommendation by study DSMC to the sponsor following interim analysis of 8 subjects.
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 blue. The aim of this study is to prove the concept that ORM-12741 can prevent these blood vessel spasms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Phenomenon
Keywords
Raynaud's phenomenon, Systemic sclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORM-12471 30mg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
ORM-12471 100mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ORM-12471 30mg
Intervention Description
Given as a single dose once during the crossover study as per Williams design
Intervention Type
Drug
Intervention Name(s)
ORM-12471
Intervention Description
Given as a single dose once during the study as per Williams crossover design
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Given once as a single dose during the study as per Williams crossover design
Primary Outcome Measure Information:
Title
Finger temperature measurements and laser doppler imaging of the hands
Description
Finger temperature measurements and laser doppler imaging of the hands will be continually monitored from 0 minutes through to 90 minutes.
Time Frame
0-90minutes continuous measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariane L Herrick, MB,ChB, MD
Organizational Affiliation
Northern Care Alliance NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salford Royal NHS foundation Trust
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24489014
Citation
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.
Results Reference
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Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon

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