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)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Hemorrhoids
• Intervention / Treatment: Drug: Relief Pro cream; Drug: Relief Pro rectal suppositories

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123423
    • State Scientific Center of Coloproctology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with acute hemorrhoids from Russia.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Drug: Relief Pro cream; Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.; Drug: Relief Pro rectal suppositories; Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of pain (VAS: Visual Analogue Scale)	Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).	Up to 14 days
Severity of bleeding (according to 4-point Likert scale)	4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).	Up to 14 days
Severity of pruritus (according to 4-point Likert scale)		Up to 14 days
Severity of swelling (according to 4-point Likert scale)		Up to 14 days
Severity (amount) of discharge (according to 4-point Likert scale)		Up to 14 days
Severity of sense of discomfort (according to 4-point Likert scale)		Up to 14 days
Overall patient satisfaction with treatment (according to 5-point Likert scale)	Likert scale: 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied), 4 (Dissatisfied) and 5 (Very dissatisfied).	Up to 14 days
Time to onset of analgesic effect after the first use of the drug		Up to 14 days
Duration of analgesic effect after the first use of the drug		Up to 14 days
Patient's adherence to recommendations of the Investigator by PRO	PRO: Patient Reported Outcome	Up to 14 days
Information obtained in the course of questioning about the consumer properties of the study product by PRO		Up to 14 days
Severity of hemorrhoids symptoms according to the Sodergren score	Standardized answer options are given (4 and 5 Likert boxes) and each question gets a score from 0 to 4.	Up to 14 days
Size of the largest hemorrhoid node measured during a routine examination		Up to 14 days
Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)		Up to 14 days
Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)		Up to 14 days
Amount of ReliefPro used based on information provided by the patient to the Investigator		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		Up to 14 days

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): October 20, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 20364

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No