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)

Acute Hemorrhoids Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757078
• Other study ID #: 20364
• Status: Completed
• Start date: November 30, 2018
• Est. completion date: October 20, 2019

Study information

• Verified date: October 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 20, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hemorrhoids
• Hemorrhoids

Intervention

Drug:
• Relief Pro cream
Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.
• Relief Pro rectal suppositories
Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice

Locations

Country	Name	City	State
Russian Federation	State Scientific Center of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Severity of pruritus (according to 4-point Likert scale)		Up to 14 days
Primary	Severity of swelling (according to 4-point Likert scale)		Up to 14 days
Primary	Severity (amount) of discharge (according to 4-point Likert scale)		Up to 14 days
Primary	Severity of sense of discomfort (according to 4-point Likert scale)		Up to 14 days
Primary	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
Primary	Time to onset of analgesic effect after the first use of the drug		Up to 14 days
Primary	Duration of analgesic effect after the first use of the drug		Up to 14 days
Primary	Patient's adherence to recommendations of the Investigator by PRO	PRO: Patient Reported Outcome	Up to 14 days
Primary	Information obtained in the course of questioning about the consumer properties of the study product by PRO		Up to 14 days
Primary	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
Primary	Size of the largest hemorrhoid node measured during a routine examination		Up to 14 days
Primary	Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)		Up to 14 days
Primary	Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)		Up to 14 days
Primary	Amount of ReliefPro used based on information provided by the patient to the Investigator		Up to 14 days
Primary	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

External Links

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