Raynaud PhenomenonNCT03393325
Tadalafil-Delivra and Raynaud's Phenomenon
An observational study of Raynaud Phenomenon, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Raynaud Phenomenon
- What is being tested?
- Observation of treatment with Tadalafil-Delivra
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2018to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients who have been prescribed Tad-Delivra for the treatment of primary or secondary Raynaud's Phenomenon with or without an active digital ulcer.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Mount Sinai Hospital
Toronto, Ontario, M5T3L9
About this study
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
A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).
Read the 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
- Being tested
- Observation of treatment with Tadalafil-Delivra
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of treatment with Tadalafil-DelivraOther
Tadalafil 2% in a Delivra base (Transdermal Application)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study startOct 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Sponsor decision. The study is not anticipated to start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud PhenomenonStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Delivra, Inc.
- Responsible party
- Sponsor
- Investigators
- Janet E Pope, MD PhD, Principal investigator, St. Joseph's Health Care, London, ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393325
- Sponsor's protocol ID
- TAD-Sc-0001
- Status last verified
- Sep 2018
- First submitted
- 22 Dec 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03393325
- Acronym / sponsor ID
- TAD-Sc-0001
- Conditions
- Raynaud Phenomenon
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision. The study is not anticipated to start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Delivra, Inc.
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have been prescribed Tad-Delivra for the treatment of primary or secondary Raynaud's Phenomenon with or without an active digital ulcer.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of treatment with Tadalafil-DelivraTadalafil 2% in a Delivra base (Transdermal Application) | Other | – |
Primary outcome
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.
3 secondary outcomes
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]
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]
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]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet E Pope, MD PhD principal investigator
St. Joseph's Health Care, London, ON
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Raynaud Phenomenon, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.