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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)

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ClinicalTrials.gov Identifier: NCT03757078
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
In this study researcher want 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 will also collect information on the treatment satisfaction of patients and their physicians with the prescribed treatment by using questionnaires. There will be 3 visits at the physician's clinic for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.

Condition or disease Intervention/treatment
Acute Hemorrhoids Drug: Relief Pro cream Drug: Relief Pro rectal suppositories

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : October 20, 2019
Actual Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Group/Cohort Intervention/treatment
Patients with acute hemorrhoids
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)
Drug: Relief Pro cream
Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.

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




Primary Outcome Measures :
  1. Change in Sodergren hemorrhoid symptom severity score by Sodergern scoring system [ 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.

  2. Change of the biggest hemorrhoid pile in size [ Time Frame: Up to 14 days ]
    Size of the biggest hemorrhoid pile measured during routine examinations

  3. Investigator overall satisfaction with Relief Pro treatment by 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).

  4. Patient's adherence to recommendations of the Investigator by PRO [ Time Frame: Up to 14 days ]
    PRO: Patient Reported Outcome

  5. Patient overall satisfaction with Relief Pro treatment by 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).

  6. Patient preferences on dosage form by PRO [ Time Frame: Up to 14 days ]
    Cream or Rectal suppository (not applicable for patients who received only one form)

  7. Date of start and end using Relief Pro [ Time Frame: Up to 14 days ]
    Assess drug utilization of Relief Pro

  8. Daily frequency of Relief Pro use, captured based on patient verbal response [ Time Frame: Up to 14 days (within period of use) ]
    Assess drug utilization of Relief Pro

  9. Change of the severity of pain symptom (VAS) [ Time Frame: Up to 14 days ]
    Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).

  10. Change of the severity of bleeding symptom (4-point Likert scale) [ Time Frame: Up to 14 days ]
    Bleeding was measured on a 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).

  11. Change of the severity of itching symptom (4-point Likert scale) [ Time Frame: Up to 14 days ]
    Itching was measured on a 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).

  12. Change of the severity of swelling symptom (4-point Likert scale) [ Time Frame: Up to 14 days ]
    Swelling was measured on a 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).

  13. Change of the severity of discharge (4-point Likert scale) [ Time Frame: Up to 14 days ]
    Discharge was measured on a 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).

  14. Change of the severity of discomfort (4-point Likert scale) [ Time Frame: Up to 14 days ]
    Discomfort were measured on a 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male and female patients with acute hemorrhoids from Russia.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757078


Locations
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Russian Federation
State Scientific Center of Coloproctology
Moscow, Russian Federation, 123423
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03757078    
Other Study ID Numbers: 20364
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Fluocortolone
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists