NCT03393325

Tadalafil-Delivra and Raynaud's Phenomenon

A Multicenter Observational Pilot Study on the Use of Tadalafil Delivra Cream in the Treatment of Raynaud's Phenomenon and Pain Associated With Digital Ulcers

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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-Delivra 2% (Tad-Del) for the treatment of RP with defined feasibility objectives and data collection through efficacy and safety assessments. Study objectives are: * At least 70% recruitment of eligible participants. * 100% data collection from at least 70% of all enrolled subjects. * Estimate the standard deviation(s) of all outcome assessments. Setting/Participants: Patients prescribed Tad-Del will be screened for study enrollment at 2 participating rheumatology clinics by the local research team. Participants that meet all the eligibility criteria will be enrolled in the study as subjects. Subjects will self-administer the medication as prescribed and return to the clinic for follow-up. Data will be collected on outcome assessments at: baseline, 1 week and at 4 to 8 weeks of treatment.

Conditions

• Raynaud Phenomenon

Interventions

Type	Name	Description
OTHER	Observation of treatment with Tadalafil-Delivra	Tadalafil 2% in a Delivra base (Transdermal Application)

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-06-01
• Completion: 2019-09-01
• First posted: 2018-01-08
• Last updated: 2018-09-20

Locations

2 sites across 1 country: Canada