check_circleStudy Completed

Acute hemorrhoids

Bayer Identifier:

20364

ClinicalTrials.gov Identifier:

NCT03757078

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

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.

Key Participants Requirements

Sex

All

Age

18 - 65 Years
  • - 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.

  • - 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
November 2018 - October 2019
Phase
N/A
Could I Receive a placebo
No
Products
BAY987052
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
State Scientific Center of ColoproctologyMoscow, 123423, Russian Federation

Primary Outcome

  • Severity of pain (VAS: Visual Analogue Scale)
    Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).
    date_rangeTime Frame:
    Up to 14 days
  • Severity of bleeding (according to 4-point Likert scale)
    4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).
    date_rangeTime Frame:
    Up to 14 days
  • Severity of pruritus (according to 4-point Likert scale)
    date_rangeTime Frame:
    Up to 14 days
  • Severity of swelling (according to 4-point Likert scale)
    date_rangeTime Frame:
    Up to 14 days
  • Severity (amount) of discharge (according to 4-point Likert scale)
    date_rangeTime Frame:
    Up to 14 days
  • Severity of sense of discomfort (according to 4-point Likert scale)
    date_rangeTime Frame:
    Up to 14 days
  • 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).
    date_rangeTime Frame:
    Up to 14 days
  • Time to onset of analgesic effect after the first use of the drug
    date_rangeTime Frame:
    Up to 14 days
  • Duration of analgesic effect after the first use of the drug
    date_rangeTime Frame:
    Up to 14 days
  • Patient's adherence to recommendations of the Investigator by PRO
    PRO: Patient Reported Outcome
    date_rangeTime Frame:
    Up to 14 days
  • Information obtained in the course of questioning about the consumer properties of the study product by PRO
    date_rangeTime Frame:
    Up to 14 days
  • 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.
    date_rangeTime Frame:
    Up to 14 days
  • Size of the largest hemorrhoid node measured during a routine examination
    date_rangeTime Frame:
    Up to 14 days
  • Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)
    date_rangeTime Frame:
    Up to 14 days
  • Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)
    date_rangeTime Frame:
    Up to 14 days
  • Amount of ReliefPro used based on information provided by the patient to the Investigator
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 14 days

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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