Otitis Media, SuppurativePhase 3NCT01244581
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
A Phase 3 study testing Amoxicillin-clavulanate in people with Otitis Media, Suppurative, run by University of Oulu at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Otitis Media, Suppurative
- What is being tested?
- Amoxicillin-clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesFinland
- Study dates
- Sep 1999to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with acute otitis media
Who cannot join
- Amoxicillin allergy
- Tympanic membrane perforation
- Tympanostomy tubes (current)
- Complication of acute otitis media such as mastoiditis
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Department of Pediatrics, Oulu University Hospital
Oulu, 90014
Lääkärikeskus Mehiläinen
Oulu, 90100
About this study
Official title: Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
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.
- Conditions
- Otitis Media, Suppurative
- Being tested
- Amoxicillin-clavulanate, Placebo
- Keywords
- middle ear effusion, amoxicillin-clavulanate, tympanometry
- Medical subject headings
- Otitis Media, Suppurative, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-clavulanateDrug
Also called Clavurion
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
PlaceboDrug
Placebo mixture in two daily doses for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin-clavulanate | Experimental | Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days Receives: Drug: Amoxicillin-clavulanate |
| Placebo | Placebo comparator | Not described Receives: Drug: Amoxicillin-clavulanate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days) to disappearance of middle ear effusion
Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.
Measured: Within 60 days
Secondary outcomes (1)
Time (days) to disappearance of pain
Measured: Within 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startSep 1999
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis Media, SuppurativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terhi Tapiainen, University of Oulu
- Investigators
- Matti Uhari, Professor, Study director, University of OuluTerhi Tapiainen, MD, PhD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244581
- Sponsor's protocol ID
- OYS_Tapiainen_001
- Status last verified
- Jun 2012
- First submitted
- 18 Nov 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, Pokka T, Alho OP, Uhari M. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr. 2014 Jul;168(7):635-41. doi: 10.1001/jamapediatrics.2013.5311.
PubMed 24797294
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
- ClinicalTrials.gov ID
- NCT01244581
- Acronym / sponsor ID
- OYS_Tapiainen_001
- Conditions
- Otitis Media, Suppurative
- Keywords
- middle ear effusion, amoxicillin-clavulanate, tympanometry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin-clavulanate | Experimental | Drug: Amoxicillin-clavulanateOral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days |
| Placebo | Placebo comparator | Drug: Amoxicillin-clavulanate, Drug: Placebo |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with acute otitis media
Key exclusion criteria (4 listed)
- Amoxicillin allergy
- Tympanic membrane perforation
- Tympanostomy tubes (current)
- Complication of acute otitis media such as mastoiditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-clavulanateAlso: ClavurionAmoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days | Drug | Amoxicillin-clavulanate, Placebo |
| PlaceboPlacebo mixture in two daily doses for 7 days | Drug | Placebo |
Primary outcome
Time (days) to disappearance of middle ear effusion
Time frame: Within 60 days
Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.
1 secondary outcome
Time (days) to disappearance of pain
Time frame: Within 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Derived from this study: PubMed 24797294Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, Pokka T, Alho OP, Uhari M. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr. 2014 Jul;168(7):635-41. doi: 10.1001/jamapediatrics.2013.5311.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matti Uhari, Professor study director
University of Oulu
Terhi Tapiainen, MD, PhD principal investigator
University of Oulu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin-clavulanate in people with Otitis Media, Suppurative, run by University of Oulu at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (days) to disappearance of middle ear effusion (time frame: Within 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01244581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.