Trial · NCT00796224
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
NCT00796224, Phase 2, Completed, Pfizer; results first posted 2010-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media. Trials, record NCT00796224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00796224
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
- NCT number
- NCT00796224
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Acute Otitis Media
- Interventions
- 60 mg/kg azithromycin ER, 30 mg/kg azithromycin IR
- First posted
- 2008-11-24
- Last updated
- 2010-02-18
- Results first posted
- 2010-01-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) | Predose/0 to 72 Hours | AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours. |
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | AUCinf = AUClast + (Clast\* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast\* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Azithromycin | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half. |
| Secondary | Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) | 1,2,3,4,8,24,48,72 hours postdose | |
| Secondary | Number of Participants With a Clinical Response | Days 7,8,9 or 10 | Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following: * Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary; * New clinical signs and symptoms of acute illness have developed and additional therapy is necessary |
| Secondary | Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to 28 days | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) | Predose/0 to 72 Hours | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | ng*hr/ml | MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | ng*hr/ml | MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Azithromycin | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | ng/ml | MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | hr | MEDIAN |
| SECONDARY | Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) | 1,2,3,4,8,24,48,72 hours postdose | All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest. | ng/ml | NUMBER |
| SECONDARY | Number of Participants With a Clinical Response | Days 7,8,9 or 10 | Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events. | participants | NUMBER |
| SECONDARY | Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to 28 days | All subjects who received at least 1 dose of study medication were included in the safety analyses. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) | 60 mg/kg Azithromycin ER | 12173.023 | Standard Deviation 6305.0325 | ng*hr/ml | |
| Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) | 30 mg/kg Azithromycin IR | 7950.949 | Standard Deviation 4759.3010 | ng*hr/ml | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) | 60 mg/kg Azithromycin ER | 15536.196 | Standard Deviation 9310.3993 | ng*hr/ml | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) | 30 mg/kg Azithromycin IR | 9645.630 | Standard Deviation 6062.6789 | ng*hr/ml | |
| Maximum Observed Plasma Concentration (Cmax) of Azithromycin | 60 mg/kg Azithromycin ER | 774.750 | Standard Deviation 477.9896 | ng/ml | |
| Maximum Observed Plasma Concentration (Cmax) of Azithromycin | 30 mg/kg Azithromycin IR | 901.644 | Standard Deviation 600.6826 | ng/ml | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | 60 mg/kg Azithromycin ER | Tmax | 3.0 | Full Range 2.0 to 8.0 | hr |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | 30 mg/kg Azithromycin IR | Tmax | 2.0 | Full Range 1.0 to 4.0 | hr |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | 60 mg/kg Azithromycin ER | t1/2 | 30.303 | Full Range 15.0 to 52.2 | hr |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin | 30 mg/kg Azithromycin IR | t1/2 | 28.959 | Full Range 10.4 to 49.0 | hr |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 60 mg/kg Azithromycin Extended-release (ER) | 19 | |
| Overall Study | STARTED | 30 mg/kg Azithromycin Immediate-release (IR) | 19 | |
| Overall Study | COMPLETED | 60 mg/kg Azithromycin Extended-release (ER) | 18 | |
| Overall Study | COMPLETED | 30 mg/kg Azithromycin Immediate-release (IR) | 18 | |
| Overall Study | NOT COMPLETED | 60 mg/kg Azithromycin Extended-release (ER) | 1 | |
| Overall Study | NOT COMPLETED | 30 mg/kg Azithromycin Immediate-release (IR) | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | 60 mg/kg Azithromycin ER | 0 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | 30 mg/kg Azithromycin IR | 1 | 19 | |
| other | Nausea | Gastrointestinal disorders | 60 mg/kg Azithromycin ER | 1 | 19 | |
| other | Nausea | Gastrointestinal disorders | 30 mg/kg Azithromycin IR | 0 | 19 | |
| other | Vomiting | Gastrointestinal disorders | 60 mg/kg Azithromycin ER | 3 | 19 | |
| other | Vomiting | Gastrointestinal disorders | 30 mg/kg Azithromycin IR | 1 | 19 | |
| other | Treatment failure | General disorders | 60 mg/kg Azithromycin ER | 0 | 19 | |
| other | Treatment failure | General disorders | 30 mg/kg Azithromycin IR | 2 | 19 | |
| other | Anorexia | Metabolism and nutrition disorders | 60 mg/kg Azithromycin ER | 0 | 19 | |
| other | Anorexia | Metabolism and nutrition disorders | 30 mg/kg Azithromycin IR | 1 | 19 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 60 mg/kg Azithromycin ER | ||
| Total, all-cause mortality | 30 mg/kg Azithromycin IR | ||
| Total, other adverse events | 60 mg/kg Azithromycin ER | 4 | 19 |
| Total, other adverse events | 30 mg/kg Azithromycin IR | 5 | 19 |
| Total, serious adverse events | 60 mg/kg Azithromycin ER | 0 | 19 |
| Total, serious adverse events | 30 mg/kg Azithromycin IR | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 60 mg/kg Azithromycin ER vs 30 mg/kg Azithromycin IR: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00796224
GET https://conductscience.org/api/trials/v1/NCT00796224/results?page=2