Clinical trial NCT03757078: Study to Find Out How Symptoms Severity Changes During the Standard Course of Treatment With the Cream Relief Pro and Suppositories Relief Pro (Active Ingredients Are Fluocortolone + Lidocaine) in Patients Suffering From Twisted and Bulging Veins in the Rectal Area (Acute Hemorrhoids)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Hemorrhoids
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients with acute hemorrhoids from Russia.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Severity of pain (VAS: Visual Analogue Scale)
timeFrame: Up to 14 days
measure: Severity of bleeding (according to 4-point Likert scale)
timeFrame: Up to 14 days
measure: Severity of pruritus (according to 4-point Likert scale)
timeFrame: Up to 14 days
measure: Severity of swelling (according to 4-point Likert scale)
timeFrame: Up to 14 days
measure: Severity (amount) of discharge (according to 4-point Likert scale)
timeFrame: Up to 14 days
measure: Severity of sense of discomfort (according to 4-point Likert scale)
timeFrame: Up to 14 days
measure: Overall patient satisfaction with treatment (according to 5-point Likert scale)
timeFrame: Up to 14 days
measure: Time to onset of analgesic effect after the first use of the drug
timeFrame: Up to 14 days
measure: Duration of analgesic effect after the first use of the drug
timeFrame: Up to 14 days
measure: Patient's adherence to recommendations of the Investigator by PRO
timeFrame: Up to 14 days
measure: Information obtained in the course of questioning about the consumer properties of the study product by PRO
timeFrame: Up to 14 days
measure: Severity of hemorrhoids symptoms according to the Sodergren score
timeFrame: Up to 14 days
measure: Size of the largest hemorrhoid node measured during a routine examination
timeFrame: Up to 14 days
measure: Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)
timeFrame: Up to 14 days
measure: Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)
timeFrame: Up to 14 days
measure: Amount of ReliefPro used based on information provided by the patient to the Investigator
timeFrame: Up to 14 days
measure: Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Center of Coloproctology
Study officials:
References: