Status:
COMPLETED
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)
Lead Sponsor:
Bayer
Conditions:
Acute Hemorrhoids
Eligibility:
All Genders
18-65 years
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 R...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 20 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03757078
Start Date
November 30 2018
End Date
October 20 2019
Last Update
October 23 2020
Active Locations (1)
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1
State Scientific Center of Coloproctology
Moscow, Russia, 123423