check_circleStudy Completed
Acute hemorrhoids
Bayer Identifier:infoA unique number for a trial given by Bayer.
20364
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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
AllAge
18 - 65 YearsTrial summary
Enrollment Goal info
1000The overall number of participants needed for a trial.
Trial Dates info
November 2018 - October 2019Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
N/AA phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
BAY987052A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | State Scientific Center of Coloproctology | Moscow, 123423, Russian Federation |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 drugdate_rangeTime Frame:Up to 14 days
- Duration of analgesic effect after the first use of the drugdate_rangeTime Frame:Up to 14 days
- Patient's adherence to recommendations of the Investigator by PROPRO: Patient Reported Outcomedate_rangeTime Frame:Up to 14 days
- Information obtained in the course of questioning about the consumer properties of the study product by PROdate_rangeTime Frame:Up to 14 days
- Severity of hemorrhoids symptoms according to the Sodergren scoreStandardized 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 examinationdate_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 Investigatordate_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 3date_rangeTime Frame:Up to 14 days
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
N/AThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.