Acute HemorrhoidsNCT03757078
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)
An observational study of Acute Hemorrhoids, run by Bayer at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Hemorrhoids
- What is being tested?
- Relief Pro cream and Relief Pro rectal suppositories
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- 30 Nov 2018to 20 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients with acute hemorrhoids from Russia.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Acute Hemorrhoids
- Being tested
- Relief Pro cream, Relief Pro rectal suppositories
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relief Pro creamDrug
Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.
Relief Pro rectal suppositoriesDrug
Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Relief Pro cream; Drug: Relief Pro rectal suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of pain (VAS: Visual Analogue Scale)
Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).
Measured: 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).
Measured: Up to 14 days
Severity of pruritus (according to 4-point Likert scale)
Measured: Up to 14 days
Severity of swelling (according to 4-point Likert scale)
Measured: Up to 14 days
Severity (amount) of discharge (according to 4-point Likert scale)
Measured: Up to 14 days
Severity of sense of discomfort (according to 4-point Likert scale)
Measured: 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).
Measured: Up to 14 days
Time to onset of analgesic effect after the first use of the drug
Measured: Up to 14 days
Duration of analgesic effect after the first use of the drug
Measured: Up to 14 days
Patient's adherence to recommendations of the Investigator by PRO
PRO: Patient Reported Outcome
Measured: Up to 14 days
Information obtained in the course of questioning about the consumer properties of the study product by PRO
Measured: 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.
Measured: Up to 14 days
Size of the largest hemorrhoid node measured during a routine examination
Measured: Up to 14 days
Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)
Measured: Up to 14 days
Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)
Measured: Up to 14 days
Amount of ReliefPro used based on information provided by the patient to the Investigator
Measured: 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
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start30 Nov 2018
- Primary completion20 Oct 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HemorrhoidsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757078
- Sponsor's protocol ID
- 20364
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2018
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03757078
- Acronym / sponsor ID
- 20364
- Conditions
- Acute Hemorrhoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute hemorrhoids | – | Drug: Relief Pro cream, Drug: Relief Pro rectal suppositoriesPatients 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients with acute hemorrhoids from Russia.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relief Pro creamRelief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice. | Drug | Patients with acute hemorrhoids |
| Relief Pro rectal suppositoriesRelief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice | Drug | Patients with acute hemorrhoids |
Primary outcome
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).
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).
Severity of pruritus (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity of swelling (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity (amount) of discharge (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity of sense of discomfort (according to 4-point Likert scale)
Time frame: Up to 14 days
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).
Time to onset of analgesic effect after the first use of the drug
Time frame: Up to 14 days
Duration of analgesic effect after the first use of the drug
Time frame: Up to 14 days
Patient's adherence to recommendations of the Investigator by PRO
Time frame: Up to 14 days
PRO: Patient Reported Outcome
Information obtained in the course of questioning about the consumer properties of the study product by PRO
Time frame: Up to 14 days
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.
Size of the largest hemorrhoid node measured during a routine examination
Time frame: Up to 14 days
Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)
Time frame: Up to 14 days
Amount of ReliefPro used based on information provided by the patient to the Investigator
Time 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
Time frame: Up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hemorrhoids, run by Bayer at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of pain (VAS: Visual Analogue Scale) (time frame: Up to 14 days). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.