TinnitusPhase 2NCT00394056
Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.
A Phase 2 study testing Vestipitant and Vestipitant + Paroxetine in people with Tinnitus, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Vestipitant and Vestipitant + Paroxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2006to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with a diagnosed tinnitus.
- Subject with THI severity grade of 3 or 4.
- Subjects willing to restrict alcohol intake.
- The subject must have given written consent.
- Women of childbearing potential who abstain from intercourse OR agree to birth control.
- Women of non-childbearing potential.
Who cannot join
- Subject with THI severity grade = 5 or less than or equal to 2.
- Subject with pathologic level of anxiety or depression.
- Subject with no audiogram deficit and with normal hearing.
- Subjects that do not respond to the lidocaine infusion test or show a large variability in pre-infusion values.
- Subjects with any serious medical or surgical condition
- Subjects positive for drug use and/or a history of substance abuse or dependence.
Show all 12Show fewer
- Subjects who have taken psychotropic drugs or antidepressants within specified time frames.
- Subjects who have recently used an investigational drug or recently participated in a trial.
- Subjects who have exhibited intolerance to NK1 antagonists or SSRIs.
- Women who have a positive pregnancy test.
- Female subjects who intend to get pregnant or male subjects who intend to father a child within the next 4 weeks following the last study drug administration in the study.
- Subjects, who have donated a unit of blood or more within the previous month or who intend to donate blood within one month of completing the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2GG
About this 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
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.
- Conditions
- Tinnitus
- Being tested
- Vestipitant, Vestipitant + Paroxetine, Placebo
- Keywords
- placebo, balanced, paroxetine, repeated dose, Hearing Loss, loudness, combination, Tinnitus, vestipitant (GW597599), randomised, annoyance, crossover
- Medical subject headings
- Tinnitus, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VestipitantDrug
NK1 receptor antagonist
Vestipitant + ParoxetineDrug
Also called Vestipitant
NK1 receptor antagonist and SSRI
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Other | Not described Receives: Drug: Vestipitant; Drug: Vestipitant + Paroxetine; Other: Placebo |
| Period 2 | Other | Not described Receives: Drug: Vestipitant; Drug: Vestipitant + Paroxetine; Other: Placebo |
| Period 3 | Other | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hrs after dosing (or at any other time point vs. pre-dose baseline).
Secondary outcomes (1)
VAS to measure tinnitus pitch, distress and anxiety. Pure Tone Audiometry & Psychoacoustic assessment. Sleep & Tinnitus questionnaires. Safety, tolerability and pharmacokinetics of drug.
Measured: perceived at the moment of the measurement at 2 hrs after dosing (or at any other time point vs. pre-dose baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394056
- Sponsor's protocol ID
- NKP106254
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2006
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Roberts C, Inamdar A, Koch A, Kitchiner P, Dewit O, Merlo-Pich E, Fina P, McFerran DJ, Baguley DM. A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus. Otol Neurotol. 2011 Jul;32(5):721-7. doi: 10.1097/MAO.0b013e318218a086.
PubMed 21646935
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00394056
- Acronym / sponsor ID
- NKP106254
- Conditions
- Tinnitus
- Keywords
- placebo, balanced, paroxetine, repeated dose, Hearing Loss, loudness, combination, Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 31 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Other | Drug: Vestipitant, Drug: Vestipitant + Paroxetine, Other: Placebo |
| Period 2 | Other | Drug: Vestipitant, Drug: Vestipitant + Paroxetine, Other: Placebo |
| Period 3 | Other | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects with a diagnosed tinnitus.
- Subject with THI severity grade of 3 or 4.
- Subjects willing to restrict alcohol intake.
- The subject must have given written consent.
- Women of childbearing potential who abstain from intercourse OR agree to birth control.
Key exclusion criteria (12 listed)
- Subject with THI severity grade = 5 or less than or equal to 2.
- Subject with pathologic level of anxiety or depression.
- Subject with no audiogram deficit and with normal hearing.
- Subjects that do not respond to the lidocaine infusion test or show a large variability in pre-infusion values.
- Subjects with any serious medical or surgical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VestipitantNK1 receptor antagonist | Drug | Period 1, Period 2 |
| Vestipitant + ParoxetineAlso: VestipitantNK1 receptor antagonist and SSRI | Drug | Period 1, Period 2 |
| PlaceboPlacebo | Other | Period 1, Period 2, Period 3 |
Primary outcome
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Background: PubMed 21646935Roberts C, Inamdar A, Koch A, Kitchiner P, Dewit O, Merlo-Pich E, Fina P, McFerran DJ, Baguley DM. A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus. Otol Neurotol. 2011 Jul;32(5):721-7. doi: 10.1097/MAO.0b013e318218a086.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vestipitant and Vestipitant + Paroxetine in people with Tinnitus, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.