Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
This study has been completed.
Sponsor:
University of Oulu
Information provided by (Responsible Party):
Terhi Tapiainen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01244581
First received: November 18, 2010
Last updated: June 19, 2012
Last verified: June 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 18, 2010 | ||||||||
| Last Updated Date | June 19, 2012 | ||||||||
| Start Date ICMJE | September 1999 | ||||||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Time (days) to disappearance of middle ear effusion [ Time Frame: Within 60 days ] [ Designated as safety issue: No ] Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry. |
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| Original Primary Outcome Measures ICMJE |
Time (days) to disappearance of middle ear effusion [ Designated as safety issue: No ] Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry. |
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| Change History | Complete list of historical versions of study NCT01244581 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Time (days) to disappearance of pain [ Time Frame: Within 60 days ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Time (days) to disappearance of pain [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry | ||||||||
| Official Title ICMJE | Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry | ||||||||
| Brief Summary | The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Otitis Media, Suppurative | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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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 | Completed | ||||||||
| Enrollment ICMJE | 84 | ||||||||
| Completion Date | June 2012 | ||||||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 16 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Finland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01244581 | ||||||||
| Other Study ID Numbers ICMJE | OYS_Tapiainen_001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Terhi Tapiainen, University of Oulu | ||||||||
| Study Sponsor ICMJE | University of Oulu | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Oulu | ||||||||
| Verification Date | June 2012 | ||||||||
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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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