Trial Condition(s):

Acute hemorrhoids

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 Identifier:

20364

ClinicalTrials.gov Identifier:

NCT03757078

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
1000
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
BAY987052
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

State Scientific Center of Coloproctology

Moscow, Russia, 123423

Status
Completed
 

Trial Design