An observational study in Raynaud Phenomenon, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Withdrawn at 2 sites in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-20.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Observational
A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).
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:
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.
81 studies on the registry are indexed under Raynaud Disease; 8 are open to participants now.
Browse Raynaud Disease studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have been prescribed Tad-Delivra for the treatment of primary or secondary Raynaud's Phenomenon with or without an active digital ulcer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tadalafil 2% in a Delivra base (Transdermal Application)
VAS-100 of DU & RP severity over the previous week assessed by patient & MD
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.
Time frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
Change in RP and DU interference in daily activities as measured by VAS-100 in SHAQ.
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.
Time frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
changes in the use of concurrent RP therapy and pain medications in patients treated with Tad-Del.
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.
Time frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
All adverse Event experienced by the patient during study participation (1st to last visit) will be recorded.
Adverse events will be summarized and reported at the end of treatment.
Time frame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2018; primary completion for Jun 2019, 8 months later.
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This study is withdrawn, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's →