NCT01973114

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

October 17, 2013

Last Update Submit

March 22, 2016

Conditions

Menière's Disease

Keywords

Menière's diseaseVertigoHearing lossTinnitus

Outcome Measures

Primary Outcomes (1)

  • Change in speech discrimination score in noise from Baseline

    2 weeks

Secondary Outcomes (7)

  • Change in speech discrimination score in noise from Baseline

    3 months

  • Change in pure tone audiometry from Baseline

    3 months

  • Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline

    3 months

  • Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period

    3 months

  • Change in proportion of days with vertigo attacks from run-in period

    3 months

  • +2 more secondary outcomes

Study Arms (4)

Group 1

EXPERIMENTAL

One intratympanic injection of latanoprost (Day1)

Drug: Latanoprost

Group 2

PLACEBO COMPARATOR

One intratympanic injection of placebo

Other: Placebo

Group 3

EXPERIMENTAL

Three intratympanic injections of latanoprost (Day 1, 2 and 3)

Drug: Latanoprost

Group 4

PLACEBO COMPARATOR

Three intratympanic injections of placebo (Day 1, 2 and 3)

Other: Placebo

Interventions

LatanoprostDRUG
Group 1Group 3
PlaceboOTHER
Group 2Group 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • Signed written informed consent

You may not qualify if:

  • 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
  • Known hypersensitivity to local anesthetics
  • Pregnant women
  • Nursing mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Falu Lasarett

Falun, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Blekinge Hospital

Karlskrona, Sweden

Location

Centralsjukhuset i Karlstad

Karlstad, Sweden

Location

Centralsjukhuset i Kristianstad

Kristianstad, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Sunderby Sjukhus

Luleå, Sweden

Location

Lund University Hospital

Lund, Sweden

Location

University Hospital Örebro

Örebro, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Västmanlands Sjukhus i Västerås

Västerås, Sweden

Location

MeSH Terms

Conditions

VertigoHearing LossTinnitus

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersSensation Disorders

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Mikael Karlberg, MD, PhD

    Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 31, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2016

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

SE(12)