- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare
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Toronto, Ontario, Canada, M5T3L9
- Mount Sinai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
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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]
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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.
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28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
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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]
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Adverse events will be summarized and reported at the end of treatment.
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28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Janet E Pope, MD PhD, St. Joseph's Health Care, London, ON
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAD-Sc-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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