Latanoprost for the Treatment of Menière's Disease

March 22, 2016 updated by: Synphora AB

A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Determine the Efficacy, the Duration of Action, and Safety of Latanoprost in Patients With Menière's Disease

The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Falun, Sweden
        • Falu lasarett
      • Göteborg, Sweden
        • Sahlgrenska Universitetssjukhuset
      • Karlskrona, Sweden
        • Blekinge Hospital
      • Karlstad, Sweden
        • Centralsjukhuset i Karlstad
      • Kristianstad, Sweden
        • Centralsjukhuset i Kristianstad
      • Linköping, Sweden
        • Linköping University Hospital
      • Luleå, Sweden
        • Sunderby Sjukhus
      • Lund, Sweden
        • Lund University Hospital
      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset
      • Uppsala, Sweden
        • Uppsala University Hospital
      • Västerås, Sweden
        • Västmanlands sjukhus i Västerås
      • Örebro, Sweden
        • University Hospital Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Definitive unilateral Menière's disease (AAO-HNS 1995)
  • Disease stage II - III: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 70dB
  • Speech discrimination score in silence: No better than 85%
  • At least three vertigo attacks (lasting ≥ 20 minutes) during the last three months prior to inclusion
  • Tinnitus during the last three months prior to inclusion
  • Signed written informed consent

Exclusion Criteria:

  • Medical or psychiatric conditions which could jeopardize or would compromise the subject's ability to participate in the trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial, dementia, alcohol or substance abuse.
  • Bilateral Menière's disease
  • Chronic otitis media on the ear affected by Menière's disease
  • Subjects not fluent in Swedish language
  • Bronchial asthma
  • Previous intratympanic injection of gentamicin or surgical therapy
  • Previous intratympanic steroid therapy less than six months prior to inclusion
  • Known hypersensitivity to local anesthetics
  • Pregnant women
  • Nursing mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
One intratympanic injection of latanoprost (Day1)
Drug: Latanoprost
Placebo Comparator: Group 2
One intratympanic injection of placebo
Other: Placebo
Experimental: Group 3
Three intratympanic injections of latanoprost (Day 1, 2 and 3)
Drug: Latanoprost
Placebo Comparator: Group 4
Three intratympanic injections of placebo (Day 1, 2 and 3)
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in speech discrimination score in noise from Baseline
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in speech discrimination score in noise from Baseline
Time Frame: 3 months
3 months
Change in pure tone audiometry from Baseline
Time Frame: 3 months
3 months
Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline
Time Frame: 3 months
3 months
Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period
Time Frame: 3 months
3 months
Change in proportion of days with vertigo attacks from run-in period
Time Frame: 3 months
3 months
Comparison of number of drop attacks in each treatment arm
Time Frame: 3 months
3 months
Evaluation of adverse events and vital signs as measure of safety and tolerability
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synphora AB

Investigators

  • Principal Investigator: Mikael Karlberg, MD, PhD, Lund University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M 05 - 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menière's Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe