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Trial record 31 of 43 for:    "Bronchial Disease" | "Azithromycin"

A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)

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ClinicalTrials.gov Identifier: NCT00254566
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : September 2, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Bronchitis
Interventions Other: Moxifloxacin Placebo
Drug: Moxifloxacin
Other: Azithromycin SR Placebo
Drug: Azithromycin SR
Enrollment 398
Recruitment Details  
Pre-assignment Details 398 subjects were enrolled and 396 subjects received treatment. Two subjects who were assigned to moxifloxacin did not receive at least one dose of treatment.
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1 Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Period Title: Overall Study
Started 198 198
Completed 167 172
Not Completed 31 26
Reason Not Completed
Death             1             0
Adverse Event             5             4
Lack of Efficacy             12             9
Other             1             5
Withdrawal by Subject             5             6
Lost to Follow-up             7             2
Arm/Group Title Azithromycin Moxifloxacin Total
Hide Arm/Group Description Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1 Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days. Total of all reporting groups
Overall Number of Baseline Participants 198 198 396
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 198 participants 396 participants
66.7  (8.7) 67.5  (8.5) 67.1  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 198 participants 396 participants
Female
18
   9.1%
21
  10.6%
39.0
Male
180
  90.9%
177
  89.4%
357.0
1.Primary Outcome
Title Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
Hide Description Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 187 191
Measure Type: Number
Unit of Measure: percent
Cure 93.0 94.2
Failure 7.0 5.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments 95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.9
Confidence Interval 95%
-5.8 to 3.9
Estimation Comments Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval
2.Secondary Outcome
Title Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)
Hide Description Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) is all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 198 198
Measure Type: Number
Unit of Measure: Percent
Cure 88.4 90.9
Failure 11.6 9.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments 95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.5
Confidence Interval 95%
-8.5 to 3.4
Estimation Comments Risk difference is the difference in the percentage of participants with Cure and the 95% CI
3.Secondary Outcome
Title Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)
Hide Description Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Clinically eligible compromised of subjects from FAS with diagnosis of chronic bronchitis, clinical evidence of AECB based on S&S, & a neg chest radiograph for pneumonia based on radiologist opinion
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 198 198
Measure Type: Number
Unit of Measure: Percent
Cure 88.4 90.9
Failure 11.6 9.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments 95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.5
Confidence Interval 95%
-8.5 to 3.4
Estimation Comments Risk difference is the difference in percentage of participants with cure and the 95% Confidence
4.Secondary Outcome
Title Percentage of Bacteriologic Response at Test of Cure Visit
Hide Description Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Bacteriologic per protocol set is compromised of subjects from the Clinical Per Protocol set with a baseline bacterial pathogen. The number of participants is the number of unique pathogens identified at baseline.
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 175 180
Measure Type: Number
Unit of Measure: Percent
Eradication 96 96.7
Persistence 4 3.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.6
Confidence Interval 95%
-4.5 to 3.3
Estimation Comments Risk difference is the difference in eradication rates of pathogens by treatment
5.Secondary Outcome
Title Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence
Hide Description Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.
Time Frame Number of Days
Hide Outcome Measure Data
Hide Analysis Population Description
Time to AECB recurrence will be analyzed for the FAS using survival analysis methods to account for censored observations. Subjects are censored at the date last known to have not experienced a recurrence. Median time to recurrence will be estimated using the Kaplan-Meier method.
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 175 180
Measure Type: Number
Unit of Measure: Days
152 204
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because <50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups’ recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.33
Confidence Interval 95%
0.9 to 2.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score
Hide Description CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis on Full Analysis Set, Last Observation Carried Forward (LOCF)-missing values at TOC visit will be imputed by carrying forward the last post-baseline observation; total score calculated by deriving the simple average of relevant items, total score is set to missing if 1 or more domain scales cannot be derived.
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 198 198
Least Squares Mean (Standard Error)
Unit of Measure: Score on Scale
-0.76  (0.112) -0.71  (0.106)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method ANCOVA
Comments Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval 95%
-0.21 to 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Mixed Models Analysis
Comments Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval 95%
-0.13 to 0.10
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score
Hide Description 1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale – 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis on Full Analysis Set, LOCF - missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 198 198
Least Squares Mean (Standard Error)
Unit of Measure: Score on Scale
-0.99  (0.129) -0.96  (0.122)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method ANCOVA
Comments Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 95%
-0.21 to 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Mixed Models Analysis
Comments Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 95%
-0.12 to 0.14
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score
Hide Description 1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis on Full Analysis Set, LOCF-missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 198 198
Least Squares Mean (Standard Error)
Unit of Measure: Score on Scale
-0.61  (0.127) -0.52  (0.120)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments [Not Specified]
Method ANCOVA
Comments Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval 95%
-0.27 to 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Mixed Models Analysis
Comments Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval 95%
-0.17 to 0.09
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score
Hide Description 1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline
Time Frame Test of Cure (TOC) Visit (Day 12-19)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis on Full Analysis Set, LOCF-missing values at TOC will be imputed by carrying forward the last post-baseline observation; Domain score is calculated by deriving the simple average of the relevant items, both mental state items must be non-missing to derive a mental state score
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description:
Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
Overall Number of Participants Analyzed 198 198
Least Squares Mean (Standard Error)
Unit of Measure: Score on Scale
-0.60  (0.142) -0.54  (0.134)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method ANCOVA
Comments Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval 95%
-0.26 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Azithromycin, Moxifloxacin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Mixed Models Analysis
Comments Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 95%
-0.18 to 0.14
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azithromycin Moxifloxacin
Hide Arm/Group Description Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1 Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
All-Cause Mortality
Azithromycin Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azithromycin Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%)
Total   4   9 
Cardiac disorders     
Acute coronary syndrome  1  0/198 (0.00%)  1/198 (0.51%) 
General disorders     
Sudden Death   1/198 (0.51%)  0/198 (0.00%) 
Infections and infestations     
Bronchitis   1/198 (0.51%)  1/198 (0.51%) 
Pneumonia   0/198 (0.00%)  1/198 (0.51%) 
Urinary tract infection   0/198 (0.00%)  1/198 (0.51%) 
Lung Infection   1/198 (0.51%)  0/198 (0.00%) 
Nervous system disorders     
Hypoxic Encephalopathy   1/198 (0.51%)  0/198 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   1/198 (0.51%)  4/198 (2.02%) 
Dyspnea   0/198 (0.00%)  2/198 (1.01%) 
Respiratory failure   1/198 (0.51%)  1/198 (0.51%) 
Acute Respiratory Failure   1/198 (0.51%)  0/198 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Azithromycin Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%)
Total   32   19 
Gastrointestinal disorders     
Abdominal pain  1  4/198 (2.02%)  1/198 (0.51%) 
Abdominal pain upper   4/198 (2.02%)  1/198 (0.51%) 
Diarrhea   18/198 (9.09%)  4/198 (2.02%) 
Nausea   1/198 (0.51%)  4/198 (2.02%) 
Infections and infestations     
Nasopharyngitis   1/198 (0.51%)  6/198 (3.03%) 
Investigations     
Alanine aminotransferase increased   4/198 (2.02%)  1/198 (0.51%) 
Aspartate aminotransferase increased   4/198 (2.02%)  0/198 (0.00%) 
Nervous system disorders     
Dizziness   1/198 (0.51%)  6/198 (3.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00254566     History of Changes
Other Study ID Numbers: A0661147
First Submitted: November 14, 2005
First Posted: November 16, 2005
Results First Submitted: July 22, 2009
Results First Posted: September 2, 2009
Last Update Posted: November 11, 2009