Status:
WITHDRAWN
Tadalafil-Delivra and Raynaud's Phenomenon
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Delivra, Inc.
Conditions:
Raynaud Phenomenon
Eligibility:
All Genders
18-75 years
Brief Summary
A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).
Detailed Description
To determine if the feasibility of conducting a future RCT using the chosen outcome assessments in RP patients at 2 Rheumatology clinics. Study Design: Observation of patients prescribed Tadalafil-D...
Eligibility Criteria
Inclusion
- Adults of both genders, Age 18 to 75 years.
- Patients with a confirmed diagnosis of Raynaud's Phenomenon (RP).
- Written informed consent.
- The presence of 1 or more digital ulcers (DU), that is not related to calcinosis, anywhere on a finger that is symptomatic for RP- defined as a VAS pain score of ≥25mm of 100mm Or 1 -3 fingers that are symptomatic for RP under standard of care treatment (SoC). Symptomatic is defined as a VAS pain score of ≥ 25mm of 100mm.
- Prescribed, but not currently being treated with Tad-Del.
- Maintenance of a stable background of prescribed treatment for RP including vasodilators, orally administered PDE5i and pain medication. Changes to administration of this concomitant medication will be documented in the case report form (CRF).
Exclusion
- Unwilling and/or incapable of adhering to the study procedures and follow-up schedule.
- Use of other prescribed topical treatment for RP, such as nitrates.
- Active infection of the index ulcer
- Calcinosis at the site of the index ulcer
- Received Iloprost or other prostacyclin treatment in the last 4 months.
- Unsuitable for study participation as determined by the clinical investigator.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03393325
Start Date
October 1 2018
End Date
September 1 2019
Last Update
September 20 2018
Active Locations (2)
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1
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T3L9