Overview

This trial is active, not recruiting.

Condition raynaud disease
Treatments 0.9% nitroglycerin in tam cream, vehicle cream
Phase phase 3
Sponsor MediQuest Therapeutics
Start date June 2009
End date June 2010
Trial size 100 participants
Trial identifier NCT00934427, 09-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
0.9% nitroglycerin in tam cream Vascana
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
(Placebo Comparator)
vehicle cream
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 Outcomes

Measure
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 Outcomes

Measure
Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
time frame: 2 weeks
Changes from baseline in duration of Raynaud's attacks
time frame: 2 weeks
Changes from baseline in number of Raynaud's attacks
time frame: 2 weeks
Changes from baseline in the Raynaud's Condition Score
time frame: 2 weeks
Changes in the maximum reduction in skin temperature
time frame: 2 weeks
Changes from baseline in overall disease severity measures
time frame: 2 weeks
Changes in the time to return to baseline skin temperature
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by MediQuest Therapeutics.