Acute Hemorrhoids Clinical Trial
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
| NCT number | NCT03757078 |
| Other study ID # | 20364 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 30, 2018 |
| Est. completion date | October 20, 2019 |
| Verified date | October 2020 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | October 20, 2019 |
| Est. primary completion date | October 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | State Scientific Center of Coloproctology | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Severity of pain (VAS: Visual Analogue Scale) | Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain). | Up to 14 days | |
| Primary | Severity of bleeding (according to 4-point Likert scale) | 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant). | Up to 14 days | |
| Primary | Severity of pruritus (according to 4-point Likert scale) | Up to 14 days | ||
| Primary | Severity of swelling (according to 4-point Likert scale) | Up to 14 days | ||
| Primary | Severity (amount) of discharge (according to 4-point Likert scale) | Up to 14 days | ||
| Primary | Severity of sense of discomfort (according to 4-point Likert scale) | Up to 14 days | ||
| Primary | 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). | Up to 14 days | |
| Primary | Time to onset of analgesic effect after the first use of the drug | Up to 14 days | ||
| Primary | Duration of analgesic effect after the first use of the drug | Up to 14 days | ||
| Primary | Patient's adherence to recommendations of the Investigator by PRO | PRO: Patient Reported Outcome | Up to 14 days | |
| Primary | Information obtained in the course of questioning about the consumer properties of the study product by PRO | Up to 14 days | ||
| Primary | 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. | Up to 14 days | |
| Primary | Size of the largest hemorrhoid node measured during a routine examination | Up to 14 days | ||
| Primary | Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale) | Up to 14 days | ||
| Primary | Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale) | Up to 14 days | ||
| Primary | Amount of ReliefPro used based on information provided by the patient to the Investigator | Up to 14 days | ||
| Primary | Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3 | Up to 14 days |