Prospective Multicenter Non-interventional Study of Fluocortolone + Lidocaine Formulation in Patients With Acute Hemorrhoids to Evaluate Changes in Symptoms Severity During the Course of Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Severity of pain (VAS: Visual Analogue Scale)
研究概览
简要总结
In this study researcher wanted to learn more about the changes of biggest twisted and bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment period with the cream Relief Pro and suppositories Relief Pro. The study collected information on the treatment satisfaction of patients and their physicians with the prescribed treatment by using questionnaires. There were 3 visits at the physician's clinic for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female patients 18 to 65 years old;
- •Patients with acute hemorrhoids 1 and 2 stage (with thrombosis (external, internal, mixed), including cases with bleeding);
- •Prescription of fluocortolone + lidocaine as a part of routine clinical practice.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice;
- •Hemorrhoid with stage ˃ II;
- •Contraindications for use of Relief PRO in the approved product label;
- •Anemia and/or severe/profuse hemorrhoid bleeding;
- •Surgery in perianal region in anamnesis;
- •Concomitant treatment with antibiotics/antiseptics, antithrombotics, antineoplastic and/or immunosuppressant;
- •Inflammatory bowel disease;
- •Hepatic diseases in severe and acute stages;
- •Colorectal cancer;
- •Purulent-inflammatory diseases of the perianal region and anal canal;
- •Chronic pulmonary diseases in severe and acute stages.
研究组 & 干预措施
Patients with acute hemorrhoids
Patients with acute hemorrhoids of 1-2 stage were prescribed Fluocortolone + Lidocaine by a physician. No drug will be provided to Patient by the Investigator, only prescription order, based on International Nonproprietary name (Fluocortolone + Lidocaine)
干预措施: Relief Pro cream (Drug)
Patients with acute hemorrhoids
Patients with acute hemorrhoids of 1-2 stage were prescribed Fluocortolone + Lidocaine by a physician. No drug will be provided to Patient by the Investigator, only prescription order, based on International Nonproprietary name (Fluocortolone + Lidocaine)
干预措施: Relief Pro rectal suppositories (Drug)
结局指标
主要结局
Severity of pain (VAS: Visual Analogue Scale)
时间窗: Up to 14 days
Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).
Severity of bleeding (according to 4-point Likert scale)
时间窗: Up to 14 days
4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).
Severity of pruritus (according to 4-point Likert scale)
时间窗: Up to 14 days
Severity of swelling (according to 4-point Likert scale)
时间窗: Up to 14 days
Severity (amount) of discharge (according to 4-point Likert scale)
时间窗: Up to 14 days
Severity of sense of discomfort (according to 4-point Likert scale)
时间窗: Up to 14 days
Overall patient satisfaction with treatment (according to 5-point Likert scale)
时间窗: Up to 14 days
Likert scale: 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied), 4 (Dissatisfied) and 5 (Very dissatisfied).
Time to onset of analgesic effect after the first use of the drug
时间窗: Up to 14 days
Duration of analgesic effect after the first use of the drug
时间窗: Up to 14 days
Patient's adherence to recommendations of the Investigator by PRO
时间窗: Up to 14 days
PRO: Patient Reported Outcome
Information obtained in the course of questioning about the consumer properties of the study product by PRO
时间窗: Up to 14 days
Severity of hemorrhoids symptoms according to the Sodergren score
时间窗: Up to 14 days
Standardized answer options are given (4 and 5 Likert boxes) and each question gets a score from 0 to 4.
Size of the largest hemorrhoid node measured during a routine examination
时间窗: Up to 14 days
Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)
时间窗: Up to 14 days
Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)
时间窗: Up to 14 days
Amount of ReliefPro used based on information provided by the patient to the Investigator
时间窗: Up to 14 days
Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3
时间窗: Up to 14 days
次要结局
未报告次要终点