Tabriz University of Medical Sciences trial of inpatient intravenous urographin plus corticosteroid versus outpatient oral corticosteroid therapy in the Sudden Sensorineural Hearing Loss

ISRCTN ISRCTN84083523
DOI https://doi.org/10.1186/ISRCTN84083523
Secondary identifying numbers N/A
Submission date
11/08/2006
Registration date
13/10/2006
Last edited
02/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Javad Totonchi
Scientific

Daneshgah Street
Imam Hospital
ENT ward
Tabriz
0098411
Iran

Study information

Study designInterventional, controlled clinical trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titleTabriz University of Medical Sciences trial of inpatient intravenous urographin plus corticosteroid versus outpatient oral corticosteroid therapy in the Sudden Sensorineural Hearing Loss
Study acronymSSHL trial
Study objectivesSudden Sensorineural Hearing Loss is a diagnosis typically made if there is a greater than 20 dB hearing loss over at least three frequencies on audiometric testing.

Hypothesis:
In-hospital and vigorous treatment with intravenous corticosteroid and urographin will improve the outcome of patients with a sudden sensorineural hearing loss when compared to an outpatient oral corticosteroid therapy.
Ethics approval(s)Approved by the Institutional Board Review and Ethics Committee, a section of Research Deputy of Faculty of Medicine at Tabriz University of Medical Sciences (TUMS).
Health condition(s) or problem(s) studiedSudden Sensorineural Hearing Loss
InterventionThe trial is not a randomised one, as we had two groups: those hospitalised and those managed on outpatient. Hospitalisation was made on the basis of patient's request.

Inpatient group received intravenous corticosteroid and intravenous urographin, while outpatient group received oral corticosteroid.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Corticosteroid and urographin
Primary outcome measureHearing recovery as shown by pure tone average on audiogram.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/01/2003
Completion date01/01/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants60
Total final enrolment51
Key inclusion criteria1. Aged over 12 years
2. A greater than 20 dB hearing loss over at least three frequencies on audiometric testing
Key exclusion criteria1. General medical condition necessitating a specific therapy
2. Incompliance to the medications
Date of first enrolment01/01/2003
Date of final enrolment01/01/2005

Locations

Countries of recruitment

  • Iran

Study participating centre

Daneshgah Street
Tabriz
0098411
Iran

Sponsor information

Tabriz University of Medical Sciences (TUMS) (Iran)
University/education

Danshgah Street
Tabriz
0098411
Iran

ROR logo "ROR" https://ror.org/04krpx645

Funders

Funder type

University/education

Tabriz University of Medical Sciences (TUMS) (Iran)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/07/2008 02/09/2021 Yes No

Editorial Notes

02/09/2021: Publication reference and total final enrolment added.