Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.
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ClinicalTrials.gov Identifier: NCT00394056 |
Recruitment Status :
Completed
First Posted : October 31, 2006
Last Update Posted : October 28, 2016
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
Tracking Information | |||||
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First Submitted Date ICMJE | October 27, 2006 | ||||
First Posted Date ICMJE | October 31, 2006 | ||||
Last Update Posted Date | October 28, 2016 | ||||
Study Start Date ICMJE | December 2006 | ||||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Visual Analog Scales (VAS) to measure the change in tinnitus loudness as perceived at the moment of the measurement at 2 hrs after dosing (or at any other time point vs. pre-dose baseline). [ Time Frame: 2 hrs after dosing (or at any other time point vs. pre-dose baseline). ] | ||||
Original Primary Outcome Measures ICMJE |
Visual Analog Scales (VAS) to measure the change in tinnitus loudness as perceived at the moment of the measurement at 2 hrs after dosing (or at any other time point vs. pre-dose baseline). | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
VAS to measure tinnitus pitch, distress and anxiety. Pure Tone Audiometry & Psychoacoustic assessment. Sleep & Tinnitus questionnaires. Safety, tolerability and pharmacokinetics of drug. [ Time Frame: perceived at the moment of the measurement at 2 hrs after dosing (or at any other time point vs. pre-dose baseline). ] | ||||
Original Secondary Outcome Measures ICMJE |
VAS to measure tinnitus pitch, distress and anxiety. Pure Tone Audiometry & Psychoacoustic assessment. Sleep & Tinnitus questionnaires. Safety, tolerability and pharmacokinetics of drug. | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss. | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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 /day), will be compared to placebo in patients suffering from tinnitus previously selected for their capacity to reliably score the transient attenuation of tinnitus loudness produced by lidocaine infusion. Effects on principal endpoints will be collected within 4 hrs from last administration, when the plasma levels of vestipitant are calculated to be in the range associated to pharmacodynamic effects on VAS anxiety and qEEG (>30 ng/ml). PK, safety and tolerability of the paroxetine-vestipitant combination was addressed with preclinical and Phase I studies, showing no relevant issue. The cross-over study will require approximately 24 patients. Audiometry and computer-based Automated Psychoacoustics will be performed as instrumental endpoints to support subjective scores. A diary will be used at home to score tinnitus severity at home during the study. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Tinnitus | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Claire Roberts, Amir Inamdar, Annelize Koch, Pauline Kitchiner, Odile Dewit, Emilio Merlo-Pich, Paolo Fina, Don J. McFerran & David M. Baguley. A Randomised, Double-blind, Placebo Controlled, Cross-over Study Comparing the Effects of Both Single and Repeated Dosing of Vestipitant or Vestipitant & Paroxetine in Treating Subjects with Moderate to Severe Tinnitus. [Otol Neurotol]. 2011;32(5):721-727. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
26 | ||||
Original Enrollment ICMJE |
24 | ||||
Actual Study Completion Date ICMJE | August 2009 | ||||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00394056 | ||||
Other Study ID Numbers ICMJE | NKP106254 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | ||||
Verification Date | October 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |