Upper Respiratory Tract InfectionPhase 3NCT00393835
A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
A Phase 3 study testing Azithromycin SR in people with Upper Respiratory Tract Infection, run by Pfizer at 5 sites in Japan.
Trial summary
To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- Azithromycin SR
- How many people
- 99 participants
- Where
- 5 sitesJapan
- Study dates
- Nov 2006to May 2007
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Who cannot join
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Pfizer Investigational Site
Gobō, Wakayama, 644-8655
Pfizer Investigational Site
Hashimoto, Wakayama, 648-0053
Pfizer Investigational Site
Shinjo-cho, Tanabe, Wakayama, 646-8588
Pfizer Investigational Site
Wakayama, Wakayama, 640-8435
Pfizer Investigational Site
Wakayama, Wakayama, 641-8510
About this study
Official title: A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin Sustained Release (SR) For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis In Japan Adults
To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- Azithromycin SR
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is Investigator's Clinical efficacy at Day 8.
Secondary outcomes (1)
Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393835
- Sponsor's protocol ID
- A0661176
- Status last verified
- May 2008
- First submitted
- 26 Oct 2006
- Last updated
- 16 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin Sustained Release (SR) For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis In Japan Adults
- ClinicalTrials.gov ID
- NCT00393835
- Acronym / sponsor ID
- A0661176
- Conditions
- Upper Respiratory Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 30 Oct 2006 (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.
To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Key exclusion criteria (1 listed)
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
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 |
|---|---|---|
| Azithromycin SR | Drug | – |
Primary outcome
The primary endpoint is Investigator's Clinical efficacy at Day 8.
1 secondary outcome
Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data
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 16 May 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
5 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 Azithromycin SR in people with Upper Respiratory Tract Infection, run by Pfizer at 5 sites 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 1 inclusion and 1 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 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The primary endpoint is Investigator's Clinical efficacy at Day 8.. 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 16 May 2008.