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)

Completed

• Conditions: Acute Hemorrhoids
• Interventions: Drug: Relief Pro cream; Drug: Relief Pro rectal suppositories

• Registration Number: NCT03757078
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2018-11-30
• Primary Completion: 2019-10-20
• Study Completion: 2019-10-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acute hemorrhoids	Relief Pro cream	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)
Patients with acute hemorrhoids	Relief Pro rectal suppositories	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)

Primary Outcome Measures

Name	Time	Method
Severity of pain (VAS: Visual Analogue Scale)	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)	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)	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)	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	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	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	Up to 14 days
Severity of hemorrhoids symptoms according to the Sodergren score	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	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

Trial Locations

Locations (1)

State Scientific Center of Coloproctology; 🇷🇺 Moscow, Russian Federation