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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- VAS-100 of DU & RP severity over the previous week assessed by patient & MD
研究概览
简要总结
A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
VAS-100 of DU & RP severity over the previous week assessed by patient & MD
时间窗: 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.
次要结局
- 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])
- 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])
- 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])