Bleeding grade I hemorrhoids
Conditions
Interventions
Product Name: HEMORRANE PLUS
Pharmaceutical Form: Rectal cream
INN or Proposed INN: HYDROCORTISONE
Current Sponsor code: Hemorrane Plus
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
FAES FARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: over 18 years. 2. Sex: both sexes. 3. Patients with grade I and II hemorrhoids. 4. Patients with pain assessed according to Visual Analogue Scale = 5 points. 5. Patients with pruritus and burning-sting evaluated according to Visual Analogue Scale = 5 points. 6. The patient must commit to comply with the hygienic-dietary measures established for the general management of hemorrhoids. 7. Urinary test of negative pregnancy in women. 8. Patients with adequate level for understanding the study. 9. The patient must have voluntarily signed the Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 185 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who have used other topical antihemorrhoids or other topical agents applicable in the same anorectal area for at least one week before the start of the study (Visit 1, day 1), nor their use throughout the study 2. Hemorrhoidal surgical intervention that is scheduled from Visit 1 (day 1) to the follow-up visit Visit 3 (day 15). 3. Severe liver disease (Child-Pugh C). 4. Severe or terminal renal failure documented in the patient's medical history. 5. Moderate to severe cardiovascular disease documented in the patient's medical history. 6. History of hypersensitivity to any of the active ingredients or components of the products under investigation. 7. Active hemorrhoidal hemorrhage or for any other cause. 8. Patients with other pathologies with symptoms similar to hemorrhoidal disease, and patients with more serious pathologies that may cause rectorrhagia. 9. Patients with bacterial, viral and / or fungal infections of the perianal region. 10. Have the diagnostic test for pancreatic puncture with bentiromide scheduled from Visit 1 (day 1) to the follow-up visit Visit 3 (day 15). 11. Be on treatment with any of the prohibited concomitant medications (sulfonamides, cholinesterase inhibitors, local ester anesthetics) for at least one week before the start of the study (Visit 1, day 1), or its use throughout the study. 12. Any other medical and / or therapeutic circumstance considered by the researcher that prevents adequate follow-up and / or adequate evolution of the response to the study treatments. 13. Pregnant women or positive pregnancy test, and lactating women. 14. Women of childbearing age who do not undertake to take the pregnancy test and use valid contraceptive methods during the study and up to one week after the end of the study. The following are considered valid contraceptive methods: barrier method (diaphragm, condom), intrauterine device (IUD), vasectomized couple, sexual abstinence, hormonal contraceptives, intrauterine system (SIU), bilateral tubal occlusion. 15. HIV positive patients known in the last five years. 16. Patients with active cancer process in the last five years. 17. Patients who have received an investigational drug (including vaccines) or have used an invasive medical device under investigation in the last 30 days prior to the start of the selection phase or are currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluar y comparar la eficacia sobre el dolor* con Hemorrane® Plus (Hemorrane®+benzocai´na), Hemorrane® y placebo en pacientes con hemorroides de grado I y II, valorado por el paciente.;Secondary Objective: 1. Evaluate and compare the speed of action on local pain relief * from Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo in patients with grade I and II hemorrhoids. 2. Evaluate and compare the efficacy of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo on local relief of pruritus, burning-stinging and bleeding assessed by the patient. 3. Evaluate and compare the efficacy of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo on local inflammation assessed by the researcher. 4. Evaluate and compare the efficacy of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo on the quality of life assessed by the patient. 5. Evaluate the safety of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo.;Primary end point(s): The main variable of the study is the percentage of patients with a decrease of two points or more on the scale - VAS * (0-10 points) of pain at T156h +30 min (day 7 hours 12 + 30min) with respect to T (0) ( day 1 hour 0).;Timepoint(s) of evaluation of this end point: T(0), T15min, T30min, T1h, T4h, T8h, T12h, T12h-15min, T12h-30min, T36h, T36h-15min, T36h-30min, T60h, T60h-15min, T60h-30min, T84h, T84h-15min, T84-30min, T108h, T108h-15min, T108h-30min, T132h, T132h-15min, T132-30min, T156h, T156h-15min, T156h-30min | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Evaluation of the speed of action on local pain relief, being considered as the time needed to achieve a variation of the Visual Analog Scale - VAS (0-10 points), with respect to the baseline value (T (0)), for each established time. 2. The evaluation of the variation of pruritus (itching that causes the need or desire to scratch) will be carried out using the Visual Analog Scale - VAS (0-10 points), assessed by the patient at the established times, with respect to the value baseline (T (0)). 3. The evaluation of the stinging-burning variation will be carried out using the Visual Analog Scale - VAS (0-10 points), assessed by the patient at the established times, with respect to the baseline value (T (0)). The evaluation of the variation of the inflammation (increase in volume, redness, local heat and pain) will be carried out by the researcher during the physical examination, using Visual Visual Scale - VAS (0-10 points) in Visit 1 (day 1) and Visit 2 (day 8), or the “Unscheduled” (unscheduled) Visit, (if any), and will be assessed with respect to the baseline value (T (0)). 5. The evaluation of bleeding (presence of red blood gleaming, in the stool, in the wash water and / or in the toilet paper after cleaning the anal area) will be performed by the patient. The investigator will ask the patient whether or not he has experienced any bleeding episode in the last week on Visit 1 (day 1) and Visit 2 (day 8), or on the “Unscheduled” (unscheduled) Visit (if any), and will be valued with respect to the baseline value (T (0)). 6. Evaluation of the patient's quality of life related to the pathology by completing the SF-36 questionnaire, evaluated by the patient on Visit 1 (day 1) and Visit 2 (day 8), or on the “Unscheduled” Visit (not programmed), (if any), and will be valued with respect to the baseline value (T (0)). The quality of life is defined as the subjective degree of well-being attributed or associated with the lack of symptoms, the psy | — |
Countries
Spain
Contacts
Public ContactNieves Fernández
FAES FARMA SA
Outcome results
None listed