Tadalafil-Delivra and Raynaud's Phenomenon

Raynaud Phenomenon Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud Phenomenon

• NCT number: NCT03393325
• Study type: Observational
• Source: Lawson Health Research Institute
• Status: Withdrawn
• Start date: October 2018
• Completion date: September 2019