Clinical Trial: Caroverin and Inner Ear Diseases
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: Phafag AG
Current Primary Outcome: 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: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: Phafag AG
Dates:
Date Received: August 2, 2010
Date Started: January 2011
Date Completion:
Last Updated: August 4, 2015
Last Verified: August 2015
