Tadalafil-Delivra and Raynaud's Phenomenon

Lawson Health Research Institute

Status: Withdrawn

Conditions: Raynaud Phenomenon

Treatments: Other: Observation of treatment with Tadalafil-Delivra

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03393325

TAD-Sc-0001

Details and patient eligibility

About

A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.