NCT00789061

Brief Summary

Disequilibrium between acid and base in the inner ear was suggested to be an important factor leading to hearing impairment associated with SLC26A4 mutations. For acid-base homeostasis in the inner ear, gastric-type proton pumps might demonstrate antagonistic effects to pendrin, the protein encoded by SLC26A4. To investigate whether proton pump inhibitors might prevent or treat acute fluctuating hearing loss related to SLC26A4 mutations, we launch the current double-blind randomized clinical trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 11, 2008

Status Verified

November 1, 2008

Enrollment Period

1.6 years

First QC Date

July 8, 2007

Last Update Submit

November 10, 2008

Conditions

Hearing Loss

Keywords

Acute hearing loss in patients with SLC26A4 mutations

Outcome Measures

Primary Outcomes (1)

  • Decrease in attack frequency or improvement of hearing loss

    3 years

Interventions

Proton pump inhibitorDRUG

One dosage/day/year

Also known as: Taquidine,Lansoprazole

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with homozygous or heterozygous SLC26A4 mutations
  • Patients with acute hearing loss

You may not qualify if:

  • Patients who do not fulfill both of the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

Proton Pump InhibitorsLansoprazole

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chuan-Jen Hsu, MD

    Department of Otolaryngology, National Taiwan University Hospital

    STUDY DIRECTOR

  • Chen-Chi Wu, MD

    Department of Otolaryngology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Chi Wu, MD

CONTACT

+886-2-23123456chenchiwu@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2007

First Posted

November 11, 2008

Study Start

August 1, 2006

Primary Completion

March 1, 2008

Study Completion

July 1, 2009

Last Updated

November 11, 2008

Record last verified: 2008-11

Locations

TW(1)