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The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin SR | Acute Bacterial Maxillary Sinusitis |
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| Amoxiclav 1000 mg | Acute Bacterial Maxillary Sinusitis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin SR | Drug | Azithromycin SR, 2.0 g by mouth (PO) x 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response of Very Convenient or Somewhat Convenient | Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'. | Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Compliance With Prescribed Treatment Regimen | Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). | Day 11 |
| Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen |
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Inclusion Criteria:
Male or nor pregnant or lactating female outpatients, 18 years of age or older.
A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:
i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice
A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:
Two or more of the following:
Exclusion Criteria:
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Patients with Acute Maxillary Sinusitis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin | A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally. |
| FG001 | Amoxiclav | Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Amoxiclav 1000 mg |
| Drug |
Amoxiclav 1000 mg x twice daily, 10 days |
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Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100. |
| Day 11 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin | A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally. |
| BG001 | Amoxiclav | Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Response of Very Convenient or Somewhat Convenient | Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'. | The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. 'N' signifies number of participants with non-missing data. Missing observations were not imputed. | Posted | Number | Percentage of Participants | Day 11 |
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| Secondary | Percent Compliance With Prescribed Treatment Regimen | Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). | The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Percent compliance | Day 11 |
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| Secondary | Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen | Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100. | The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. | Posted | Number | Percentage of Participants | Day 11 |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithromycin | A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally. | 0 | 63 | 7 | 63 | ||
| EG001 | Amoxiclav | Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days. | 0 | 60 | 9 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D015523 | Maxillary Sinusitis |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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