Acute Lower Urinary Tract InfectionPhase 3NCT02439632
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
A Phase 3 study testing prulifloxacin and Levofloxacin in people with Acute Lower Urinary Tract Infection, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated lower urinary tract infection in chinese Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Acute Lower Urinary Tract Infection
- What is being tested?
- prulifloxacin and Levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
- Patients are hypersensitive to quinolones or with allergic constitution;
- Administration of xanthines, fenbufen, antibiotics or antibacterials within the two previous weeks;
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- Patients with severe condition which need combination with other antibacterial agents or corticosteroids during the study;
- 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)
- Patients with severe liver or kidney disease, defined as serum ALT and AST ≥ 2.5 x ULN and creatinine ≥ 1.5 x ULN;
- Patients with severe heart disease or Q-T prolongation indicated by 12-lead ECG, or arrhythmia or acute myocardial ischemia;
- WBC < 3.6 × 109/L or neutrophil < 1.8 × 109/L, and/or platelets < 90 × 109/L at screening;
- Patients with central nervous system disease or convulsion history, and/or with mental status unable to coordinate;
- Patients with malignant tumor or other severe background disease;
- Patients with severe immunodeficiency;
- Patients with a history of tendinopathy or who are currently having the disease, including tendinitis and tendon rupture;
- Patients treated with experimental drugs in the previous 4 weeks or currently;
- Considered inappropriate for the study by investigators, including patients who are unable or unwilling to show compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated lower urinary tract infection in chinese
- Conditions
- Acute Lower Urinary Tract Infection
- Being tested
- prulifloxacin, Levofloxacin, Prulifloxacin Placebo, Levofloxacin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prulifloxacinDrug
LevofloxacinDrug
Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days.
Prulifloxacin PlaceboDrug
Placebo of prulifloxacin film-coated tablet without active components.
Levofloxacin PlaceboDrug
Placebo of levofloxacin hydrochloride tablet without active components.
| Study group | Role | What they receive |
|---|---|---|
| prulifloxacin | Experimental | Prulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet.
Placebo of levofloxacin hydrochloride tablet without active components. Receives: Drug: prulifloxacin; Drug: Levofloxacin Placebo |
| Levofloxacin | Active comparator | Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days.
Placebo of prulifloxacin film-coated tablet, without active components. Receives: Drug: Levofloxacin; Drug: Prulifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of prulifloxacin film-coated tablet was meaured by the number of patient have been cured
600mg single dose prolifloxacin is not inferior to Levoflxacin on low urine infection in Chinese
Measured: 3 days
Secondary outcomes (1)
The safety of prulifloxacin film-coated tablet was measured by the number fo AE and SAE
- The susceptibility of infecting strains to prulifloxacin;
- The rate of return to normal of WBC (white blood cell) in urine in treatment and control group
- The safety and tolerability of prulifloxacin in adult patients with acute lower urinary tract infection
Measured: 3 days and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lower Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439632
- Sponsor's protocol ID
- Prulifloxacin aulut ZK-004
- Status last verified
- May 2015
- First submitted
- 4 Jun 2014
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02439632
- Acronym / sponsor ID
- Prulifloxacin aulut ZK-004
- Conditions
- Acute Lower Urinary Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated lower urinary tract infection in chinese
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prulifloxacin | Experimental | Drug: prulifloxacin, Drug: Levofloxacin PlaceboPrulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet. Placebo of levofloxacin hydrochloride tablet without active components. |
| Levofloxacin | Active comparator | Drug: Levofloxacin, Drug: Prulifloxacin PlaceboLevofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days. Placebo of prulifloxacin film-coated tablet, without active components. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
- Patients are hypersensitive to quinolones or with allergic constitution;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prulifloxacin | Drug | prulifloxacin |
| LevofloxacinLevofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days. | Drug | Levofloxacin |
| Prulifloxacin PlaceboPlacebo of prulifloxacin film-coated tablet without active components. | Drug | Levofloxacin |
| Levofloxacin PlaceboPlacebo of levofloxacin hydrochloride tablet without active components. | Drug | prulifloxacin |
Primary outcome
The efficacy of prulifloxacin film-coated tablet was meaured by the number of patient have been cured
Time frame: 3 days
600mg single dose prolifloxacin is not inferior to Levoflxacin on low urine infection in Chinese
1 secondary outcome
The safety of prulifloxacin film-coated tablet was measured by the number fo AE and SAE
Time frame: 3 days and 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prulifloxacin and Levofloxacin in people with Acute Lower Urinary Tract Infection, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of prulifloxacin film-coated tablet was meaured by the number of patient have been cured (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.