Randomised double-blind, placebo-controlled, cross-over study comparing the effects of single dose and repeated dosing treatment for 14 days of vestipitant / paroxetine combination in an enriched population of subjects with tinnitus and hearing loss
- Conditions
- TinnitusMedDRA version: 8.1 Level: LLT Classification code 10043882 Term: Tinnitus
- Registration Number
- EUCTR2006-003295-36-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•Male or female subjects diagnosed with tinnitus according to a standard audiology visit and examination, including otoscopy and audiograms
•Subject with a THI severity grade of mild or greater (THI >= 18, [Newman, 1998]).
•Subjects must be 18-65 years of age inclusive.
•The subject must have the ability to comprehend the key components of the consent form and must have given written informed consent to participate in the study prior to commencing any study specific procedures.
•Women of childbearing potential, who have a negative urine pregnancy test result at screening and pre-dose on Day 1 for all the 3 treatment sessions, must be able to commit to either of the following:
Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug,
OR
Agrees to consistent and correct use of an acceptable method of birth control; GSK acceptable Contraceptive Methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
a.Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
b.Oral contraceptives (either combined or progestogen only);
Double-barrier method of contraception consisting of condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository);
IUD with a documented failure rate of less than 1% per year;
If subjects indicate they will remain abstinent during the period described above, they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active.
•Women of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria apply - see protocol for full list of criteria:
•Subject with a THI of grade of No handicap” [Newman, 1998] i.e. THI score of less than 18.
•Subjects with one of the following medical conditions:
a. Subjects with any serious medical disorder or condition that would, in the investigator's opinion, preclude the administration of vestipitant or paroxetine
b. Existence of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
c. Subjects with known Meniere Disease or Otosclerosis.
d. Subjects with a 12-lead ECG at screening, which in the opinion of the Principal Investigator or physician designee has abnormalities that will compromise safety in this study. Specific exclusion criteria with regard to QT interval (either QTcb or QTcf, machine or manual over-read, males or females) are as follows:
•QTc >=450 msec, based on single or average QTc value of triplicate ECGs obtained over a brief recording period.
e. Subjects with laboratory parameters outside the reference range for this age group will only be included if the Principal Investigator or designe considers that such findings will not introduce additional risk factors. In any case, liver function tests (bilirubin, ALT, AST or alkaline phosphatase) must be below 1.5 fold higher than the upper limit of normal at screening.
f. Subjects positive for hepatitis C antibody or hepatitis B surface antigen
g. Subjects who are not euthyroid based on clinical examination and laboratory results at the Screening Visit. Subjects maintained on thyroid medication must be euthyroid for a period of at least six months prior to the Screening Visit.
h. Subjects with current or past history of clinically significant hepatic (subjects with hepatic impairment [ALT, AST, bilirubin, alkaline phosphatase, GGT must be below 1.5 fold higher than hte upper limit of normal screening] or a history of liver dysfunction), cardiac, renal (serum creatinine higher than 124umol/l), neurologic, cerebrovascular, metabolic, pulmonary disease or gastrointestinal bleeding.
i. Subjects with a current condition of, or history of psychosis.
j. Subjects who have had a myocardial infarction within 1 year prior to screening visit.
k. Subjects with current or past history of seizure disorders (except for febrile seizures in childhood).
l. Subjects with known or past history of cancer
m. Subjects with current or past clinically significant history of drug or other allergy (atopy) which, in the opinion of the Investigator, contraindicates the subject's participation in the study.
• Current or history of (within 6 months of study) regular alcohol consumption defined as:
- For males: an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
- For females: an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units.
-One unit is equivalent to a half-pint (220mL) of beer or 1 (125 mL) measure of s
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method