Tadalafil-Delivra and Raynaud's Phenomenon
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|ClinicalTrials.gov Identifier: NCT03393325|
Recruitment Status : Withdrawn (Sponsor decision. The study is not anticipated to start)
First Posted : January 8, 2018
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment|
|Raynaud Phenomenon||Other: Observation of treatment with Tadalafil-Delivra|
To determine if the feasibility of conducting a future RCT using the chosen outcome assessments in RP patients at 2 Rheumatology clinics.
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
- Other: Observation of treatment with Tadalafil-Delivra
Tadalafil 2% in a Delivra base (Transdermal Application)
- VAS-100 of DU & RP severity over the previous week assessed by patient & MD [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]Visual Analogue Scale (VAS) of the severity of Digital Ulcers (DU) and Raynaud's Phenomenon (RP). The physician (MD) and patient will each independently make their own assessment on a linear 10 cm VAS scale by making a mark on the line with a pen anywhere from the left anchor "0" (indicating no disease at all) to the right anchor "10" (indicating the most severe imaginable). Both the MD and patient will complete an individual scale for RP and DU. The distance of the mark from the left anchor "0" will be recorded in mm, divided by 10 and reported as a value from 0 to 10. A total of 4 VAS scales will be completed.
- Change in RP and DU interference in daily activities as measured by VAS-100 in SHAQ. [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]Visual Analogue Scales for Raynaud's Phenomenon and Digital Ulcer interference in daily activities as measured by the patient. Both assessments are part of the Scleroderma Health Assessment Questionnaire (SHAQ). The patient will make an assessment on the linear VAS scale for each by making a mark on the line with a pen anywhere from the left anchor "Does not limit activities" to the right anchor "Very Severe limitation". The distance of the mark from the left to the right anchor will be measured in mm, divided by 10 and reported as a value from 0 to 10. There are two scales: 1 for Raynaud's Phenomena and the other for Digital Ulcer.
- changes in the use of concurrent RP therapy and pain medications in patients treated with Tad-Del. [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]Concomitant medication use at the end of treatment (day 28-56) will be compared with concomitant medication use at baseline with respect to daily dose administered.
- All adverse Event experienced by the patient during study participation (1st to last visit) will be recorded. [ Time Frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed] ]Adverse events will be summarized and reported at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393325
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5T3L9|
|Principal Investigator:||Janet E Pope, MD PhD||St. Joseph's Health Care, London, ON|