SYNOPSIS
Name of Sponsor/Company

Daiichi Sankyo Co., Ltd.

Name of Finished Product

CRAVIT ® INTRAVENOUS DRIP INFUSION

Name of Active Ingredient

Levofloxacin

Title of Study

Clinical study of DR-3355 injection in patients with acutebacterial prostatitis or acute epididymitis

Investigators
Study Centre(s)6 sitesPublication (reference)

None

Studied Period

Date of obtaining first consent: July, 2012
Date of last observation: February, 2013

Phase of Development

Phase 3

Objectives

The purpose of this study is to evaluate efficacy and safetyof DR-3355 injection on acute bacterial prostatitis or acuteepididymitis.

Methodology

Multicenter, Open-label study

Number of Patients (plannedPlanned: 18 subjects

and analyzed)

Registered: 18 subjects
Analyzed:

Analysis set of efficacy (PPS)
Analysis set of safety

13 subjects
18 subjects

Diagnosis and Main Criteria

Diagnosis: Acute bacterial prostatitis, Acute bacterialfor Inclusion

epididymitis, Acute chlamydial epididymitis
Inclusion criteria:
1) Patients with age of 20 and over at the time of obtaining
informed consents.
2) Patients with symptoms of acute prostatitis or acuteepididymitis.
3) Patients who meet the criteria for pyuria and havebacteria in the urine
4) Patients who require an injection treatment. (any of thefollowing symptoms: pain and swelling of the epididymis,
temperature of 38 degrees or more, nausea or vomiting,dehydration, suspicion of bacteremia, urine flow failure,anorexia, diarrhea)
Exclusion criteria:
1) Patients who have indwelling catheter in the urinary
tract.

2) Patients whose urinary tract is routed through bowels.
3) Patients who had a prostate biopsy immediately prior toenrollment.
4) Patients whose symptoms have shown improvement
due to the administration of other antibacterial agentswithin 7 days prior to the test drug administration.
5) Patients with infectious diseases for whom levofloxacin
did not work obviously, or patients having fungus that has
been detected in a bacteria test prior to this trial.
6) Patients with urinary tract infection other than target
diseases (acute prostatitis or acute epididymitis).
7) Patients who have received levofloxacin within 30 days
prior to the test drug administration.
8) Patients with a history of allergy/severe adverse effects
to quinolone antibacterial agents.
9) Patients with a history of seizure/epilepsy/disturbanceof consciousness.
10) Patients who have difficulty in judging the efficacy of
thestudy drug (including patients suffering fromprogressive cancer or other underlying diseases which
prevent the evaluation).
11) Patients with severe hepatic impairment, renalimpairment, or cardiac impairment.
12)

Patients

whorequireprohibitedconcomitant

medications or treatments in this study.
13) Patients who participated in any other clinical trials
within 30 days prior to this trial.
14) Patients who have participated in the clinical trial ofDR-3355 injection previously, and have been treated withthe test drug.
15) Other patients who are judged to be inappropriate by
the investigator
Test Product, Dose and Mode

Test product (batch number):of Administration, Batch

DR-3355inj (D3355I0H11T01A)

NumberLevofloxacin tablet (D3355F0S11T01A)
Dosage and administration:
Intravenous administration of DR-3355inj at 500 mg,
once daily

Oral administration of levofloxacin at 500 mg, once daily
Duration of Treatment

14 to 21 days
DR-3355inj is administered for three days at least, andthen, is switched to levofloxacin tablet at the discretion of
the investigator in accordance with clinical symptoms(defervescenceand/orimprovement).

Duration

ofadministration including oral is 14 to 21 days.
Reference Therapy, Dose andModeof

None

Administration,

Batch Number
Criteria for Evaluation

Primary: Bacteriological efficacy at the test of cure
Secondary:1) Bacteriological and clinical efficacy, and bacteriologicalefficacy of different types of bacteria at the end of injection
treatment
2) Clinical efficacy and bacteriological efficacy of different
types of bacteria at the test of cure3) Bacteriological and clinical efficacy at the test ofrecurrence

Statistical Method

Primary: The point estimate of the bacteriological efficacy
rate and the two-sided 95% confidence interval arecalculated by diagnosis.
Secondary:

Thepoint

estimateof

thebacteriological/clinical efficacy rate and the two-sided 95%
confidence interval are calculated by diagnosis.
Summary - Conclusion

Efficacy summary:
The primary endpoint was bacteriological efficacy rate at
the test of cure in PPS. The efficacy rate was 83.3% (5/6) inpatients with acute bacterial prostatitis, and 83.3% (5/6)
inpatientswithacutebacterialorchlamydialepididymitis. The clinical efficacy rate at the test of curewas 83.3% (5/6) in patients with acute bacterial
prostatitis, and 66.7% (4/6) in patients with acutebacterial or chlamydial epididymitis.
Safety summary:
The incidence of adverse events was 38.9% (7/18) in thewhole period, and adverse events that occurred in 2 or

more were not reported. One subject was discontinued
administration of investigational drug by mild contact
dermatitis of adverse event . Incidence of adverse drug
reactions was 22.2% (4/18) in the whole period. All adverse
events were mild in severity, all subjects who had adverse
eventswererecoveredwithorwithout

medicaltreatments.
Conclusion:
From these results, DR-3355inj (including switch therapy
to levofloxacin oral agent) is useful for treatment of acutebacterial prostatitis and acute bacterial or chlamydial
epididymitis and there is no important problem in thesafety.
Date of Report

July 8, 2014