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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00394056 |
Tinnitus associated to hearing loss is a high prevalent audiologic disorder with important unmet needs as far as therapy is concerned. The present study is exploring the possible beneficial effects on tinnitus loudness or annoyance of a combination drug treatment aimed to increase the local inhibitory activity of neural circuitries involved in sound perception and generation. Modest effects have been reported after 8-12 weeks treatment with antidepressants, including high dose paroxetine (up to 50 mg/day). Biologic data suggests that the combination of increase of extracellular serotonin using an SSRI and of blockade of NK1 receptors using a novel NK1 antagonist may lead to a reduced tinnitus and, possibly, improved hearing acuity. To this aim, two 14 day treatment conditions, i.e., SSRI paroxetine (20 mg/day) plus the NK1 antagonist vestipitant (25mg /day) or vestipitant alone (25 mg
Condition | Intervention | Phase |
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Tinnitus |
Drug: Vestipitant Drug: Vestipitant + Paroxetine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Randomised, Double-Blind, Placebo Controlled, Cross-Over Study Comparing the Effects of Both Single Dose and Repeated Dosing Treatment for 14 Days of Vestipitant or Vestipitant / Paroxetine Combination in an Enriched Population of Subjects With Tinnitus & Hearing Loss |
Estimated Enrollment: | 24 |
Study Start Date: | November 2006 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United Kingdom | |
GSK Clinical Trials Call Centre | Recruiting |
Cambridge, United Kingdom, CB2 2GG | |
Contact: GSK Clinical Trials Call Centre 1-877-379-8718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | NKP106254 |
Study First Received: | October 27, 2006 |
Last Updated: | July 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00394056 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
randomised placebo crossover balanced repeated dose vestipitant (GW597599) |
paroxetine combination Tinnitus Hearing Loss loudness annoyance |
Sensation Disorders Neurotransmitter Agents Otorhinolaryngologic Diseases Psychotropic Drugs Tinnitus Ear Diseases Paroxetine Serotonin Uptake Inhibitors |
Serotonin Signs and Symptoms Deafness Hearing Disorders Neurologic Manifestations Antidepressive Agents, Second-Generation Hearing Loss Antidepressive Agents |
Sensation Disorders Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs Tinnitus Ear Diseases Paroxetine Serotonin Uptake Inhibitors |
Pharmacologic Actions Signs and Symptoms Deafness Hearing Disorders Serotonin Agents Therapeutic Uses Neurologic Manifestations Antidepressive Agents, Second-Generation Hearing Loss Central Nervous System Agents Antidepressive Agents |