Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Caroverin and Inner Ear Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01174979
Recruitment Status : Suspended (due to less patient the study was suspended)
First Posted : August 4, 2010
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Phafag AG

Tracking Information
First Submitted Date  ICMJE August 2, 2010
First Posted Date  ICMJE August 4, 2010
Last Update Posted Date August 7, 2015
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2010)
to investigate the efficacy of Caroverin in transtympanic treatment of patients with tinnitus measured by a visual analogue scale. [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2010)
  • to investigate the time from the start of treatment to an improvement in tinnitus [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ]
  • to investigate the efficacy of Caroverin depending the origin of tinnitus [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ]
  • to investigate the safety of Caroverin treatment [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ]
  • to investigate the impact of Caroverin treatment of quality of life [ Time Frame: treatment takes 5 days, follow up examination 4 weeks after ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caroverin and Inner Ear Diseases
Official Title  ICMJE Double Blind, Placebo-controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Transtympanic Treatment of Tinnitus With Caroverine
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE Drug: Caroverin
treatment with eardrops 2 times for 48 hours
Study Arms  ICMJE
  • Experimental: Caroverin
    Intervention: Drug: Caroverin
  • Placebo Comparator: Placebo
    Intervention: Drug: Caroverin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: August 2, 2010)
170
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Diseases or conditions that may be associated with an altered perception or processing of stimuli, e.g. mental illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01174979
Other Study ID Numbers  ICMJE 1-09
2009-018046-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phafag AG
Study Sponsor  ICMJE Phafag AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wolfgang Elsaesser, Dr. Landeskrankenhaus Feldkirch
PRS Account Phafag AG
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP