Effect of Gabapentin on Idiopathic Subjective Tinnitus
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | November 8, 2007 | ||||
| Last Updated Date | January 5, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin. [ Time Frame: two months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by thre patient's scoring it from one to ten, before and after prescribing Gabapentin. [ Time Frame: two months ] | ||||
| Change History | Complete list of historical versions of study NCT00555776 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Relieve of complications of tinnitus, such as sleep difficulties. [ Time Frame: two months ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Gabapentin on Idiopathic Subjective Tinnitus | ||||
| Official Title ICMJE | Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus | ||||
| Brief Summary | The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus. |
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| Detailed Description | Tinnitus is the perception of sound in the absence of acoustic stimulation. It can be subjective or objective. . Despite numerous researches,no effective treatment for people who suffer from tinnitus has yet been stablished. As there are many evidences suggesting that loss of inhibition in the central nervous system may be responsible for many aspects of auditory dysfunction,including tinnitus; and as Gabapentin (Neurontin), a gama-aminobutyric acid (GABA) analogue, is an effective medication in conditions where inhibition in the CNS is impaired; we guess that Gabapentin might be useful for treating idiopathic subjective tinnitus. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Subjective Tinnitus | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Bakhshaee M, Ghasemi M, Azarpazhooh M, Khadivi E, Rezaei S, Shakeri M, Tale M. Gabapentin effectiveness on the sensation of subjective idiopathic tinnitus: a pilot study. Eur Arch Otorhinolaryngol. 2007 Oct 25; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Estimated Completion Date | October 2008 | ||||
| Estimated Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00555776 | ||||
| Other Study ID Numbers ICMJE | Gaba-tinntus-145 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr.Mahboobeh Adami Dehkordi, Assisstant professor | ||||
| Study Sponsor ICMJE | Islamic Azad University of Mashhad | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Islamic Azad University of Mashhad | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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