Clinical trial NCT03393325: Tadalafil-Delivra and Raynaud's Phenomenon
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Raynaud Phenomenon
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Delivra, Inc.
First posted: 2018-01-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. Adults of both genders, Age 18 to 75 years.
2. Patients with a confirmed diagnosis of Raynaud's Phenomenon (RP).
3. Written informed consent.
4. 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.
5. Prescribed, but not currently being treated with Tad-Del.
6. 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:

1. Unwilling and/or incapable of adhering to the study procedures and follow-up schedule.
2. Use of other prescribed topical treatment for RP, such as nitrates.
3. Active infection of the index ulcer
4. Calcinosis at the site of the index ulcer
5. Received Iloprost or other prostacyclin treatment in the last 4 months.
6. Unsuitable for study participation as determined by the clinical investigator.

Primary outcomes:
measure: VAS-100 of DU & RP severity over the previous week assessed by patient & MD
timeFrame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
Secondary outcomes:
measure: Change in RP and DU interference in daily activities as measured by VAS-100 in SHAQ.
timeFrame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
measure: changes in the use of concurrent RP therapy and pain medications in patients treated with Tad-Del.
timeFrame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
measure: All adverse Event experienced by the patient during study participation (1st to last visit) will be recorded.
timeFrame: 28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care, London, ON
name: Janet E Pope, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: