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Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis

NCT01617057 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-11-06

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid, Skelid®, Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis

Conditions

  • Otosclerosis

Interventions

DRUG

tiludronic acid

400 mg / day for 3 months

DRUG

Placebo

400 mg / day for 3 month

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alexis BOZORG-GRAYELI, Pr · Hôpital Général, CHU de Dijon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-03-31
Completion
2017-07-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01617057 on ClinicalTrials.gov