Clinical trial NCT02439632: A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control
Official title: A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Lower Urinary Tract Infection
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated lower urinary tract infection in chinese


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 \~ 65 years old;
2. Presence at least two of the following clinical signs and symptoms of acute uncomplicated lower urinary tract infection: dysuria, frequency, urgency and suprapubic pain) with onset of symptoms ≤ 72 hours prior to study entry;
3. With pyuria: WBC \> 10/mm3 in unspun urine examined in a counting chamber or WBC \> 5/hp \[or the Upper laboratory Norm (UNL)\] in the resuspended sediment of a centrifuged aliquot of urine (or the UNL);
4. Patient is willing to participate in the study and gives the signature of informed consent form;

Exclusion Criteria:

1. Presence of clinical signs and symptoms suggestive of pyelonephritis or complicated urinary tract infection (e.g., fever \> 37.5°C, chills, flank pain), or with factors associated with complicated urinary tract infections such as presence of an indwelling catheter or urologic abnormalities;
2. Women who are pregnant, nursing or plan to become pregnant in the near future (i.e., in three months). Women of childbearing potential (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential) must have a negative serum pregnancy test at screening and must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, barrier methods (intra-uterine device, diaphragm, female condom, male condom);
3. Three or more episodes of acute uncomplicated UTI in the past 12 months;
4. Patients with overactive bladder;
5. Patients are hypersensitive to quinolones or with allergic constitution;
6. Administration of xanthines, fenbufen, antibiotics or antibacterials within the two previous weeks;
7. Patients with severe condition which need combination with other antibacterial agents or corticosteroids during the study;
8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, Inflammatory bowel disease, lactose intolerance, or malabsorption syndrome)
9. Patients with severe liver or kidney disease, defined as serum ALT and AST ≥ 2.5 x ULN and creatinine ≥ 1.5 x ULN;
10. Patients with severe heart disease or Q-T prolongation indicated by 12-lead ECG, or arrhythmia or acute myocardial ischemia;
11. WBC \< 3.6 × 109/L or neutrophil \< 1.8 × 109/L, and/or platelets \< 90 × 109/L at screening;
12. Patients with central nervous system disease or convulsion history, and/or with mental status unable to coordinate;
13. Patients with malignant tumor or other severe background disease;
14. Patients with severe immunodeficiency;
15. Patients with a history of tendinopathy or who are currently having the disease, including tendinitis and tendon rupture;
16. Patients treated with experimental drugs in the previous 4 weeks or currently;
17. Considered inappropriate for the study by investigators, including patients who are unable or unwilling to show compliance with the protocol.

Primary outcomes:
measure: The efficacy of prulifloxacin film-coated tablet was meaured by the number of patient have been cured
timeFrame: 3 days
Secondary outcomes:
measure: The safety of prulifloxacin film-coated tablet was measured by the number fo AE and SAE
timeFrame: 3 days and 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Medical Union Hospital
Study officials:
References: