Otitis MediaPhase 3NCT00000363
Acute Otitis Media: Adjuvant Therapy to Improve Outcome
A Phase 3 study testing Antihistamine and Corticosteroid in people with Otitis Media, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial summary
Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. Read more about this study
- Who is it for?
- Ages 2 months to 1 year
- Conditions the study is for
- Otitis Media
- What is being tested?
- Antihistamine and Corticosteroid
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2001
- 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 2 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have had two documented prior episodes of acute otitis media.
- Have no current middle ear effusion (fluid).
Who cannot join
- Have chronic otitis media.
- Have acute otitis media in addition to chronic otitis media.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Texas Med Branch Children's Hosp
Galveston, Texas, 77550
About this study
Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.
- Conditions
- Otitis Media
- Being tested
- Antihistamine, Corticosteroid
- Keywords
- Antibiotics, Adrenal Cortex Hormones, Histamine H1 Antagonists, Infant, Otitis Media
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntihistamineDrug
CorticosteroidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies 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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Tasnee Chonmaitree, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000363
- Sponsor's protocol ID
- NIDCD-1160
- Other IDs
- R01DC002620-04
- Status last verified
- Apr 2006
- First submitted
- 2 Nov 1999
- Last updated
- 24 Apr 2006
- Results posted
- No
Publications
Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH Jr, McCormick DP. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003 Sep;143(3):377-85. doi: 10.1067/S0022-3476(03)00293-2.
PubMed 14517524McCormick DP, Saeed K, Uchida T, Baldwin CD, Deskin R, Lett-Brown MA, Heikkinen T, Chonmaitree T. Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment. Int J Pediatr Otorhinolaryngol. 2003 Mar;67(3):221-30. doi: 10.1016/s0165-5876(02)00372-5.
PubMed 12633920
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Otitis Media: Adjuvant Therapy to Improve Outcome
- ClinicalTrials.gov ID
- NCT00000363
- Acronym / sponsor ID
- NIDCD-1160
- Conditions
- Otitis Media
- Keywords
- Antibiotics, Adrenal Cortex Hormones, Histamine H1 Antagonists, Infant, Otitis Media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study completion
- Jun 2001
- First posted
- 3 Nov 1999 (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.
Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 2 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Have had two documented prior episodes of acute otitis media.
- Have no current middle ear effusion (fluid).
Key exclusion criteria (2 listed)
- Have chronic otitis media.
- Have acute otitis media in addition to chronic otitis media.
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 |
|---|---|---|
| Antihistamine | Drug | – |
| Corticosteroid | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Apr 2006.
- Background: PubMed 14517524Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH Jr, McCormick DP. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003 Sep;143(3):377-85. doi: 10.1067/S0022-3476(03)00293-2.
- Background: PubMed 12633920McCormick DP, Saeed K, Uchida T, Baldwin CD, Deskin R, Lett-Brown MA, Heikkinen T, Chonmaitree T. Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment. Int J Pediatr Otorhinolaryngol. 2003 Mar;67(3):221-30. doi: 10.1016/s0165-5876(02)00372-5.
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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.
Dr. Tasnee Chonmaitree study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antihistamine and Corticosteroid in people with Otitis Media, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
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 2 inclusion and 2 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 24 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000363, which also lists 2 linked publications.
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 24 Apr 2006.