Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257270
Status:
COMPLETED
Last Update Posted:
2005-11-22
First Post:
2005-11-18
Brief Title:
The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Sponsor:
Tinnitus Research Consortium
Organization:
Tinnitus Research Consortium
Study Overview
Official Title:
The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group but would be less effective in the non-trauma group
Detailed Description:
Methods A prospective placebo-controlled single-blind study of the effect of gabapentin on tinnitus was employed Audiograms and personal histories were used to categorize tinnitus etiology as either secondary to acoustic trauma or not associated with acoustic trauma Participants were restricted to those with moderate-to-severe tinnitus for at least one year All participants received gabapentin in a graduated ascending-descending dose series over 20 weeks peak dose of 2400 mgday
Results There was a significant improvement in tinnitus annoyance for the trauma group p 005 Other subjective aspects of tinnitus were not significantly affected in either group Between-subject variability of therapeutic response was considerable Nevertheless considering subjective loudness ratings 419 non-trauma participants and 620 trauma participants showed an improvement of 20 percent or better Considering psychoacoustic loudness estimates 419 non-trauma and 620 trauma participants showed a 15 dB HL improvement Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mgday for the trauma high-response subgroup p 0007 No significant improvement was obtained for other subgroups
Results There was a significant improvement in tinnitus annoyance for the trauma group p 005 Other subjective aspects of tinnitus were not significantly affected in either group Between-subject variability of therapeutic response was considerable Nevertheless considering subjective loudness ratings 419 non-trauma participants and 620 trauma participants showed an improvement of 20 percent or better Considering psychoacoustic loudness estimates 419 non-trauma and 620 trauma participants showed a 15 dB HL improvement Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mgday for the trauma high-response subgroup p 0007 No significant improvement was obtained for other subgroups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None