Deanxit and Rivotril in Tinnitus Patients

Antwerp University Hospital (UZA)

Status and phase: Completed; Phase 4

Conditions: Tinnitus

Treatments: Drug: Deanxit; Drug: Lactose placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00841230

8/46/260

Details and patient eligibility

About

The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pure tone, narrow band noise or polyphonic tinnitus

• unilateral or bilateral tinnitus

• VAS ≥ 4

  • cochleair origin tinnitus
  • tinnitus present 3 months or more
  • age 18y or more
  • intake Rivotril 1mg/d
  • patient 'able to cooperate'
  • patient able to fill in TQ en VAS
  • No pontine angle pathology on MRI

Exclusion criteria

• pulsatile tinnitus
• pregnancy or breast feeding
• contra-indications Deanxit
• recovery myocard infarct
• conduction disorder His
• untreated glaucoma
• MAO inhibitors: 15d stop
• otosclerosis
• middle ear pathologies
• Ménière
• somatic tinnitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Lactose placebo

Placebo Comparator group

Description:

1x/day

Treatment:

Drug: Lactose placebo

Deanxit

Experimental group

Treatment:

Drug: Deanxit