Assessment of the effect of rivaroxaban as adjuvant treatment for improvement of Idiopathic sudden sensorineural hearing loss
Design
Clinical trial with control group, with parallel group,double blind, randomized group, 3 phase on 140 patients.
Settings and conduct
140 patients who have referred to the emergency department of AmirAl-Momenin hospital in Rasht with sudden hearing loss are randomly divided into 2 groups.Patients hearing status will be assessed with audiometry before starting treatment and 2 weeks after and 3 months after starting treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients18 to 65 years of age with a unilateral sudden sensory hearing loss that Less than 5 days have passed since the onset of the patient's symptoms and a hearing loss of ≥ 30 dB at least in 3 consecutive frequencies in the audiometery
Exclusion criteria:
history of hearing loss, trauma to the ear, active ear infection, congenital cochlear disease
Use of ototoxic drugs, anticoagulants, anticonvulsants.
Cardiovascular disease, coagulation disorders, and diabete
Retrocochlear lesions
Severe renal and hepatic impairment
People with neoplasms who have not been treated or are being treated with chemotherapy or radiotherapy
pregnancy and Breastfeeding
history of autoimmune disorder
platelet count disorder
Intervention groups
The first group received standard oral treatment with prednisolone at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 days (10 mg daily decreases) and valaciclovir 500 mg each. 8 hours (3 times a day) for 7 days and pantoprazole 40 mg daily (for 15 days) and in addition to the above treatment, rivaroxaban is prescribed at a dose of 20 mg daily for 10 days. In the second group, standard treatment and placebo with the same form as rivaroxaban are given.
Main outcome variables
Pure tone audiometry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200708048051N1
Registration date:2020-08-01, 1399/05/11
Registration timing:prospective
Last update:2020-08-01, 1399/05/11
Update count:0
Registration date
2020-08-01, 1399/05/11
Registrant information
Name
Malihe Akbarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3261 9301
Email address
akbarpour@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of rivaroxaban as Adjuvant Treatment for improvement of Idiopathic Sudden Sensorineural Hearing Loss
Public title
Assessment of the effect of rivaroxaban on sudden sensorineural hearing loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a unilateral sudden sensory hearing loss
Refer to the hospital in less than 5 days from the onset of symptoms
Hearing loss of ≥ 30 dB at least 3 consecutive frequencies in the audiometery.
Exclusion criteria:
Patients with a history of hearing loss, trauma to the ear, active ear infection, congenital cochlear disease
Use of ototoxic drugs, anticoagulants, anticonvulsants.
Cardiovascular disease, coagulation disorders, and diabetes.
Retro cochlear lesions
Severe renal and hepatic impairment (Cr clearance less than 15)
People with neoplasms who have not been treated or are being treated with chemotherapy or radiotherapy.
pregnancy and breastfeeding
Patients with history of autoimmune disorder
Patients with platelet count disorder (less than 150,000)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
After receiving the explanations about the project, the mentioned patients are divided into two control group and intervention group by permuted block randomization. Blocking is usually used to balance in number of assigned samples to each one of studied groups. This feature helps researchers to in cases that mid-term analyzes are required during the sampling process, number of samples assigned to each of the study groups be equal,First, the software prepares a list of 4 blocks in which an equal number of people are randomly placed in two groups A and B. This list is placed in a separate envelope and then the envelope is closed and given to a third party. If the patient is referred to and qualified, one of the pocket is given to the patient, according to the number. After filling the forms, the pocket is opened and a patient is treated according to the desired number and receives the related intervention. Patients and researchers will not be informed of the type of received intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
individuals under study, physicians caring for patients and those assessing outcomes and study researchers are kept blind to specific study groups. after selecting patients medications are given to patients in un named and similar envelopes by third person, and the list of patients in each group will not be disclosed until the end of data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice-chancellor for Research Building, opposite of Sepah Bank, Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
4139637459
Approval date
2020-07-01, 1399/04/11
Ethics committee reference number
IR.GUMS.REC.1399.131
Health conditions studied
1
Description of health condition studied
Idiopathic Sudden Sensorineural Hearing Loss
ICD-10 code
H91.20
ICD-10 code description
Sudden idiopathic hearing loss, unspecified ear
Primary outcomes
1
Description
Hearing threshold
Timepoint
Before starting treatment and 2 weeks after and 3 months after starting treatment
Method of measurement
Pure tone audiometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prednisolone (Nisopred ®, Iranhormone Co.) tablets at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 days (10 mg daily decreases) and valaciclovir (Virabex ® , Abidi Co.) 500 mg every 8 hours (3 times a day) ) For 7 days and pantoprazole (Abidi Co.) 40 mg daily (for 15 days) and rivaroxaban (Xalerban ®, Abidi Co.) at a dose of 20 mg daily for 10 days
Category
Treatment - Drugs
2
Description
Control group: Prednisolone (Nisopred ®, Iranhormone Co.) tablets at a dose of 1 mg / kg daily (maximum 60 mg as a single dose in the morning) for 10 days and then taper for 5 days (10 mg daily decreases) and valaciclovir (Virabex ® , Abidi Co.) 500 mg every 8 hours (3 times a day) ) For 7 days and pantoprazole (Abidi Co.) 40 mg daily (for 15 days) and placebo with the same form as rivaroxaban for 10 days