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)

Bayer

Status: Completed

Conditions: Acute Hemorrhoids

Treatments: Drug: Relief Pro rectal suppositories; Drug: Relief Pro cream

Study type: Observational

Funder types: Industry

Identifiers

NCT03757078

20364

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Patients with acute hemorrhoids

Description:

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)

Treatment:

Drug: Relief Pro cream

Drug: Relief Pro rectal suppositories