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OpenTrials
Completed

NCT Number: NCT03757078

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)

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.

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Key information

Conditions

Acute Hemorrhoids

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

State Scientific Center of Coloproctology

Moscow, 123423, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relief Pro cream

Drug

Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.

Relief Pro rectal suppositories

Drug

Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice

Primary outcomes

  1. Severity of pain (VAS: Visual Analogue Scale)

    Time frame: Up to 14 days

    Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).

  2. Severity of bleeding (according to 4-point Likert scale)

    Time frame: Up to 14 days

    4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).

  3. Severity of pruritus (according to 4-point Likert scale)

    Time frame: Up to 14 days

  4. Severity of swelling (according to 4-point Likert scale)

    Time frame: Up to 14 days

  5. Severity (amount) of discharge (according to 4-point Likert scale)

    Time frame: Up to 14 days

  6. Severity of sense of discomfort (according to 4-point Likert scale)

    Time frame: Up to 14 days

  7. Overall patient satisfaction with treatment (according to 5-point Likert scale)

    Time frame: Up to 14 days

    Likert scale: 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied), 4 (Dissatisfied) and 5 (Very dissatisfied).

  8. Time to onset of analgesic effect after the first use of the drug

    Time frame: Up to 14 days

  9. Duration of analgesic effect after the first use of the drug

    Time frame: Up to 14 days

  10. Patient's adherence to recommendations of the Investigator by PRO

    Time frame: Up to 14 days

    PRO: Patient Reported Outcome

  11. Information obtained in the course of questioning about the consumer properties of the study product by PRO

    Time frame: Up to 14 days

  12. Severity of hemorrhoids symptoms according to the Sodergren score

    Time frame: Up to 14 days

    Standardized answer options are given (4 and 5 Likert boxes) and each question gets a score from 0 to 4.

  13. Size of the largest hemorrhoid node measured during a routine examination

    Time frame: Up to 14 days

  14. Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)

    Time frame: Up to 14 days

  15. Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)

    Time frame: Up to 14 days

  16. Amount of ReliefPro used based on information provided by the patient to the Investigator

    Time frame: Up to 14 days

  17. Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3

    Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.