Tadalafil-Delivra and Raynaud's Phenomenon

NCT03393325 | Withdrawn

• 1 other identifier: TAD-Sc-0001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Raynaud Phenomenon

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  28 days [this assessment has a window of an additional 28 days (Day 56) to be completed]

Interventions

Observation of treatment with Tadalafil-Delivra OTHER

Tadalafil 2% in a Delivra base (Transdermal Application)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Delivra, Inc.: collaborator

Study Sites (2)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T3L9, Canada

Location

MeSH Terms

Conditions

Raynaud Disease

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janet E Pope, MD PhD

  St. Joseph's Health Care, London, ON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 8, 2018
• Study Start: October 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)