Clinical trial: AM-101 in the Treatment of Acute Tinnitus 2 (NCT01803646)

Eligibility criteria:
Inclusion Criteria:

          1. Persistent subjective peripheral tinnitus (unilateral or bilateral) following
             traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery,
             inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer
             than 3 months prior to randomization

          2. Age ≥ 18 years and ≤ 75 years (≥ 14 years and ≤ 75 years at selected sites);

          3. Negative pregnancy test (woman of childbearing potential);

          4. Willing and able to use adequate hearing protection, respectively to refrain from
             engaging in activities or work involving loud noise exposure where sufficient hearing
             protection is not possible or ensured;

          5. Willing and able to protect ear canal and middle ear from water exposure as long as
             tympanic membrane is not fully closed.

        Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          1. Fluctuating tinnitus;

          2. Intermittent tinnitus;

          3. Tinnitus resulting from traumatic head or neck injury;

          4. Presence of chronic tinnitus;

          5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing
             loss;

          6. History of repeated idiopathic sudden sensorineural hearing loss or history of
             acoustic neuroma;

          7. Ongoing acute or chronic otitis media or otitis externa;

          8. Other treatment of tinnitus for the study duration;

          9. Known hypersensitivity, allergy or intolerance to the study medication or any history
             of severe, abnormal drug reaction;

         10. Women who are breast-feeding, pregnant or who are planning to become pregnant during
             the study;

         11. Women of childbearing potential who are unwilling or unable to practice contraception,
             such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with
             a partner who has been vasectomised for at least three months;

         12. Concurrent participation in another clinical study or participation in another
             clinical study within 30 days prior to randomization.

        Other protocol-defined exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment