Condition category
Ear, Nose and Throat
Date applied
03/02/2005
Date assigned
09/02/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eckart Klemm

ORCID ID

Contact details

HNO-Klinik Krankenhaus Dresden-Friedrichstadt
Friedrichstr. 41
Dresden
01067
Germany
+49 (0)351 480 1220
Raehder-Co@khdf.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HS-13-26-EU

Study information

Scientific title

Acronym

Study hypothesis

Objective: Obtain first data on HES 130/0.4 (hydroxyethyl starch) as monotherapy in patients with acute idiopathic sudden sensorineural hearing loss (ISSNHL).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Sudden hearing loss

Intervention

Infusion of 750 ml per day with HES 45 g per day (group H), 30 g per day (M), 15 g per day (L), or glucose 5% (G) acting as 'placebo' control over 6 days.

Intervention type

Drug

Phase

Not Specified

Drug names

Hydroxyethyl starch

Primary outcome measures

Absolute hearing gain (AHG) in decibel at Day 7, calculated as mean audiometric hearing threshold (MAHT) at baseline minus MAHT at Day 7, whereby MAHT was the arithmetic mean of the hearing thresholds in dB at the main speech frequencies of 0.5, 1, 2, 3, and 4 kilohertz

Secondary outcome measures

Efficacy:
1. AHG at other timepoints (i.e. Days 3, 14, and 90)
2. AHG based on geometric MAHT
3. Hearing gain based on the Schwab/Ewert formula i.e. the arithmetic mean of the delogarithmed pure tone thresholds
4. AHG based on arithmetic and geometric MAHT calculated only on speech frequencies with an initial hearing loss of 20 dB or more
5. Outcome categorised in complete/partial/no recovery or deterioration
6. Changes of subjective hearing, vertigo, and tinnitus

Safety:
1. Adverse events
2. Laboratory parameters (haematology, haemostasis, clinical chemistry, urinalysis)
3. Vital signs

Overall trial start date

01/11/2000

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

210 inpatients with first-time idiopathic sudden sensorineural hearing loss (ISSNHL) of 20 dB or more at two or more frequencies and 95 dB or less at all of the speech frequencies (0.5, 1.0, 2.0, 3.0, 4.0 kHz) with respect to the other (normal) ear for up to 7 days.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

210

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2000

Recruitment end date

31/12/2002

Locations

Countries of recruitment

Germany

Trial participating centre

HNO-Klinik Krankenhaus Dresden-Friedrichstadt
Dresden
01067
Germany

Sponsor information

Organisation

Fresenius Kabi Deutschland GmbH (Germany)

Sponsor details

Else Kröner Str. 1
Bad Homburg v.d.H
61352
Germany
+49 (0)6172 686 7324
Daniela.Baus@fresenius-kabi.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Fresenius Kabi Deutschland GmbH (Germany) (ref: HS-13-26-EU)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes