Otitis MediaPhase 3NCT00638534
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
A Phase 3 study testing Telithromycin (HMR3647) in people with Otitis Media, run by Sanofi at 1 site in Japan.
Trial summary
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM). Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Telithromycin (HMR3647)
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2004to Oct 2004
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
- Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety, Efficacy, Pharmacokinetics, and Acceptability of HMR3647 20 mg/kg qd for 5 Days With Acute Otitis Media (AOM) in Children (Multicenter, Open Label, Non Comparative Study)
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM).
Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.
- Conditions
- Otitis Media
- Being tested
- Telithromycin (HMR3647)
- Keywords
- Acute Otitis Media, AOM, children, Child
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telithromycin (HMR3647)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Secondary outcomes (3)
Clinical efficacy: tympanic signs
Acceptability: compliance and willingness to take medication
Pharmacokinetics: plasma concentrations of telithromycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startFeb 2004
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638534
- Sponsor's protocol ID
- EFC6370
- Other IDs
- HMR3647B/3103
- Status last verified
- Oct 2009
- First submitted
- 12 Mar 2008
- Last updated
- 2 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Efficacy, Pharmacokinetics, and Acceptability of HMR3647 20 mg/kg qd for 5 Days With Acute Otitis Media (AOM) in Children (Multicenter, Open Label, Non Comparative Study)
- ClinicalTrials.gov ID
- NCT00638534
- Acronym / sponsor ID
- EFC6370
- Conditions
- Otitis Media
- Keywords
- Acute Otitis Media, AOM, children, Child
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 19 Mar 2008 (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 primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM).
Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
- Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telithromycin (HMR3647) | Drug | – |
Primary outcome
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
3 secondary outcomes
Clinical efficacy: tympanic signs
Acceptability: compliance and willingness to take medication
Pharmacokinetics: plasma concentrations of telithromycin
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 2 Oct 2009.
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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.
CSD study director
Sanofi
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 Telithromycin (HMR3647) in people with Otitis Media, run by Sanofi at 1 site in Japan.
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 3 inclusion and 0 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 2 Oct 2009. 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 Japan. 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.
What does the primary outcome measure?
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2009.