Trial record 7 of 18 for:    "Meniere disease"

Latanoprost for the Treatment of Menière's Disease

This study is currently recruiting participants.
Verified November 2013 by Synphora AB
Sponsor:
Information provided by (Responsible Party):
Synphora AB
ClinicalTrials.gov Identifier:
NCT01973114
First received: October 17, 2013
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Menière's Disease
Drug: Latanoprost
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Synphora AB:

Primary Outcome Measures:
  • Change in speech discrimination score in noise from Baseline [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in speech discrimination score in noise from Baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in pure tone audiometry from Baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in proportion of days with vertigo attacks from run-in period [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Comparison of number of drop attacks in each treatment arm [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Evaluation of adverse events and vital signs as measure of safety and tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Definitive unilateral Menière's disease (AAO-HNS 1995)
  • Disease stage II - IV: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 65dB
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01973114

Contacts
Contact: Fredrik Henell, Dr Med Sci + 46 70 325 38 47 fredrik.henell@synphora.com

Locations
Sweden
Falu Lasarett Recruiting
Falun, Sweden
Sahlgrenska Universitetssjukhuset Recruiting
Göteborg, Sweden
Centralsjukhuset i Karlstad Recruiting
Karlstad, Sweden
Centralsjukhuset i Kristianstad Recruiting
Kristianstad, Sweden
Sunderby Sjukhus Recruiting
Luleå, Sweden
Lund University Hospital Recruiting
Lund, Sweden
Karolinska Universitetssjukhuset Recruiting
Stockholm, Sweden
Västmanlands Sjukhus i Västerås Recruiting
Västerås, Sweden
University Hospital Örebro Recruiting
Örebro, Sweden
Sponsors and Collaborators
Synphora AB
Investigators
Principal Investigator: Mikael Karlberg, MD, PhD Lund University Hospital
  More Information

No publications provided

Responsible Party: Synphora AB
ClinicalTrials.gov Identifier: NCT01973114     History of Changes
Other Study ID Numbers: M 05 - 2013
Study First Received: October 17, 2013
Last Updated: November 10, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Synphora AB:
Menière's disease
Vertigo
Hearing loss
Tinnitus

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014