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. 2014 Jan 1;23(1):77–104. doi: 10.1089/jwh.2012.4171

Table 4.

Characteristics of Published Phase-4 Clinical Trials of Moxifloxacina

First author Journal No. subjects (% women) Age Research focus Objective Limiting omission
Grassi et al.175
USA
J Chemother (2002)
423 (21.3)
69.3±8.4
AECB
To compare the efficacy and tolerability of a 5-day treatment course with oral MXF vs a 7-day course with intramuscular ceftriaxone in 476 patients with acute exacerbations of chronic bronchitis, and to conduct a cost minimization analysis of the two treatments from the perspectives of both the Italian National Health Service and society
Sex not included in the design
Not enough women
Miratvilles et al.176
Spain
Int J Clin Pract (2001)
5,736 (35.4)
66
AECB
To examine the clinical effect of oral MXF on patients' signs and symptoms of AECB
Sex not included in the design
Not enough women
Lorenz et al.177
USA
J Int Med Res (2001)
332 (46.1)
16–93
AECB
To compare with the macrolides azithromycin, clarithromycin and roxithromycin in a cohort study to assess clinical, safety, and health-related outcomes of these antimicrobials in general practice settings
Enough women, sex was not considered in the design or data analysis
Koch et al.178
USA
Clin Drug Investig (2004)
1,146 (47.3)
54.3±18.2
CAP
To assess the efficacy, safety and tolerability of oral MXF in outpatients with respiratory tract infections treated in general practices in Germany with the focus on CAP
Sex analysis was performed
Sex not considered in the design
Landen et al.179
Germany
J Int Med Res (2001)
15,959 (48.7)
14–60
CAP
To study of the speed, efficacy and tolerability of MXF when used in clinical practice for the treatment of CAP or AECB
Enough women, sex was not considered in the design or data analysis
Barth et al.180
Germany
Clinical Drug Investigation (2005)
1,749 (43.5)
43.4±14.3
Pneumonia
To investigate the efficacy, safety, and tolerability of sequential i.v./o.p. therapy with MXF in pneumonia under general hospital treatment conditions.
Enough women, sex was not considered in the design or data analysis
Liu et al.181
China
Int J Clin Pract (2007)
3,184 (41.0)
20–79
Respiratory tract infections
To assess the efficacy and tolerability of MXF post marketing
Sex analysis performed
Sex not considered in the design.
Chen et al.182
China
Clin Drug Investig (2006)
855 (41.1)
50.4±18.5
Respiratory tract infections
To assess the efficacy, safety and tolerability of oral MXF in patients with respiratory tract infections treated by attending physicians in routine clinical practice in China
Sex analysis performed
Sex not considered in the design
Faich et al.183
USA
Ann Pharmacother (2004)
18,299 (61.9)
6–97
Respiratory tract infections
To further investigate MXF's general and cardiac safety and evaluate its efficacy in the community practice setting in a large surveillance study
Enough women, sex was not considered in the design or data analysis
Elies et al.184
Germany
Clin Drug Investig (2004) 2,405 (56.8) 43.4±14.3 Sinusitis To assess the efficacy, safety and tolerability of MXF in patients with respiratory tract infections treated in general practice in Germany Enough women, sex was not considered in the design or data analysis
a

Ordered by research focus and percentage of women participating in the clinical trials.

Phase 4: postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use.