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Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

Primary Purpose

Raynaud Disease

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0.9% nitroglycerin in TAM cream
vehicle cream
Sponsored by
MediQuest Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud Disease focused on measuring Raynaud's, scleroderma, nitroglycerin, MQX-503, treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
  • a history of at least two Raynaud's events during a typical winter day
  • must be willing to apply creams to fingers
  • must be willing to undergo cold temperature exposure
  • must be willing and able to stop certain medications
  • must be willing to use effective contraception, if applicable

Exclusion Criteria:

  • had a Raynaud's attack that required hospital or clinic intervention
  • has allergies to nitroglycerin or topical medication ingredients
  • has a history of migraine or chronic pain
  • has an unstable medical problem that could interfere with the study
  • had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
  • used any investigational drug in the past 4 weeks
  • has significantly abnormal laboratory tests
  • had certain major surgeries in the past 6 months
  • has skin lesions on certain parts of the fingers
  • women who are pregnant or nursing

Sites / Locations

  • Stanford University
  • University of Connecticut
  • Massachusetts General Hospital
  • University of Michigan
  • Michigan State University
  • University of Minnesota
  • University of Medicine and Dentistry in New Jersey
  • Carolina Arthritis
  • Cleveland Clinic
  • University of Toledo
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vascana

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)

Secondary Outcome Measures

Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
Changes from baseline in duration of Raynaud's attacks
Changes from baseline in number of Raynaud's attacks
Changes from baseline in the Raynaud's Condition Score
Changes in the maximum reduction in skin temperature
Changes from baseline in overall disease severity measures
Changes in the time to return to baseline skin temperature

Full Information

First Posted
June 26, 2009
Last Updated
July 19, 2010
Sponsor
MediQuest Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00934427
Brief Title
Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
Official Title
A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
MediQuest Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
Detailed Description
Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud Disease
Keywords
Raynaud's, scleroderma, nitroglycerin, MQX-503, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vascana
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
0.9% nitroglycerin in TAM cream
Other Intervention Name(s)
Vascana
Intervention Description
0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
Intervention Type
Drug
Intervention Name(s)
vehicle cream
Intervention Description
0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures
Primary Outcome Measure Information:
Title
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
Time Frame
2 weeks
Title
Changes from baseline in duration of Raynaud's attacks
Time Frame
2 weeks
Title
Changes from baseline in number of Raynaud's attacks
Time Frame
2 weeks
Title
Changes from baseline in the Raynaud's Condition Score
Time Frame
2 weeks
Title
Changes in the maximum reduction in skin temperature
Time Frame
2 weeks
Title
Changes from baseline in overall disease severity measures
Time Frame
2 weeks
Title
Changes in the time to return to baseline skin temperature
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers a history of at least two Raynaud's events during a typical winter day must be willing to apply creams to fingers must be willing to undergo cold temperature exposure must be willing and able to stop certain medications must be willing to use effective contraception, if applicable Exclusion Criteria: had a Raynaud's attack that required hospital or clinic intervention has allergies to nitroglycerin or topical medication ingredients has a history of migraine or chronic pain has an unstable medical problem that could interfere with the study had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months used any investigational drug in the past 4 weeks has significantly abnormal laboratory tests had certain major surgeries in the past 6 months has skin lesions on certain parts of the fingers women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Gregory, MD
Organizational Affiliation
MediQuest Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Michigan State University
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Medicine and Dentistry in New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Carolina Arthritis
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

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