CompletedPhase 3

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

China216 participantsStarted 2014-02

Plain-language summary

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

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients aged 18 \~ 65 years old;
✓. 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;
✓. 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);
✓. Patient is willing to participate in the study and gives the signature of informed consent form;

✕. 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;
✕. 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);
✕. Three or more episodes of acute uncomplicated UTI in the past 12 months;
✕. Patients with overactive bladder;

The efficacy of prulifloxacin film-coated tablet was meaured by the number of patient have been cured

Timeframe: 3 days

NCT IDNCT02439632

SponsorLee's Pharmaceutical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients aged 18 \~ 65 years old;
✓. 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;
✓. 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);
✓. Patient is willing to participate in the study and gives the signature of informed consent form;

✕. 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;
✕. 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);
✕. Three or more episodes of acute uncomplicated UTI in the past 12 months;
✕. Patients with overactive bladder;