Caroverin and Inner Ear Diseases

NCT01174979 | Suspended Phase 3 DMC

• 2 other identifiers: 1-092009-018046-38
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a randomized, double blind, placebo controlled study on patients suffering from inner ear diseases with tinnitus as a principal symptom. The study will investigate the transtympanic treatment with a 1,5 % caroverine solution. Each patient will undergo treatment for 2 cycles of 48 hours each.

Conditions

Tinnitus

Keywords

Morbus Meniere; Sudden hearing loss; Blast injury; Presbyacusis; Chron. Otitis Media

Outcome Measures

Primary Outcomes (1)

• to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale.

  treatment takes 5 days, follow up examination 4 weeks after

Secondary Outcomes (4)

• to investigate the time from the start of treatment to an improvement in tinnitus

  treatment takes 5 days, follow up examination 4 weeks after

• to investigate the efficacy of Caroverin depending the origin of tinnitus

  treatment takes 5 days, follow up examination 4 weeks after

• to investigate the safety of Caroverin treatment

  treatment takes 5 days, follow up examination 4 weeks after

• to investigate the impact of Caroverin treatment of quality of life

  treatment takes 5 days, follow up examination 4 weeks after

Study Arms (2)

Caroverin

EXPERIMENTAL

Drug: Caroverin

Placebo

PLACEBO COMPARATOR

Drug: Caroverin

Interventions

Caroverin DRUG

treatment with eardrops 2 times for 48 hours

Caroverin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged at least eighteen
• Written consent to take part in the study after receiving information from the trial physician
• One of the following illnesses:
• Decompensated tinnitus
• Sudden hearing loss
• Morbus Menière
• Blast injury
• Presbyacusis with Tinnitus
• Chron. Otitis media

You may not qualify if:

• Patients who are not able to give their consent (e.g. dementia, coma, mental disability,…)
• Women of childbearing age who are not using adequate contraception or who are (or plan to become) pregnant (a pregnancy test must be carried out by a doctor once a month in Austria) or are lactating
• If there are solid reasons to doubt that the patient would be willing and able to cooperate
• Known intolerance of/hypersensitivity to caroverine
• Subjects who have taken part in another clinical trial within the 30 days preceding the start of this study or during this study
• Pulse-synchronous tinnitus
• Tinnitus caused by malposition of the jaw bone (bruxism)
• Eardrum perforation
• Subjects who have previously had a barotraumas, diving accidents or decompression sickness
• Retrocochlear hearing disorder
• Patients who have previously had a fracture of the petrous bone
• Subjects suffering from acute or chronic accompanying conditions which severely impede their general health (NYHA stage IV, cancer, HIV etc.)
• Accompanying conditions that according to the current state of scientific knowledge could affect the parameters used in this study to such an extent as to make it impossible to perform an objective assessment of those parameters, particularly ear conditions, including any conditions affecting the other ear or conditions like HI NYHA stage IV, cancer, HIV, Wallenberg Syndrome, massive Hypotension, Glaucoma.)
• Accompanying medication that according to the current state of scientific knowledge are likely to affect the measurement techniques used in this study or the results obtained (cytostatics, aminoglycoside antibiotics, loop diuretics (furosemide, etacrynic acid), psycho pharmaceuticals, muscle relaxants, benzodiazepines, salicylates, quinine, cortisone and/or caroverine within the three days preceding the start of the study)
• Drug treatment for tinnitus or sudden hearing loss (i.v. and oral) within seven days preceding the start of the study where the total duration of the course is less than four weeks

Sponsors & Collaborators

• Phafag AG: lead

Study Sites (1)

Landeskrankenhaus Feldkirch

Feldkirch, Vorarlberg, 6800, Austria

Location

MeSH Terms

Conditions

Tinnitus; Hearing Loss, Sudden; Blast Injuries; Presbycusis

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss; Barotrauma; Wounds and Injuries; Hearing Loss, Sensorineural

Study Officials

• Wolfgang Elsaesser, Dr.

  Landeskrankenhaus Feldkirch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

AU (1)