UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011518
Receipt number R000013465
Scientific Title Evaluation of the drug interaction between magnesium oxide and levofloxacin
Date of disclosure of the study information 2013/08/19
Last modified on 2013/08/19 20:05:52

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Basic information

Public title

Evaluation of the drug interaction between magnesium oxide and levofloxacin

Acronym

Interaction of magnesium oxide and levofloxacin

Scientific Title

Evaluation of the drug interaction between magnesium oxide and levofloxacin

Scientific Title:Acronym

Interaction of magnesium oxide and levofloxacin

Region

Japan


Condition

Condition

Patients who decided prophylactic administration of levofloxacin is necessary

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Breast surgery Obstetrics and Gynecology Oto-rhino-laryngology
Urology Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the interaction between levofloxacin and magnesium oxide in feeding condition

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

area under the blood concentration-time curve (AUC)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of levofloxacin alone

Interventions/Control_2

co-administration of levofloxacin and magnesium oxide

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients receiving levofloxacin for prevention of bacterial infections
2) Signed informed consent
3) Age >= 20 and < 75 years
4) ECOG performance status: 0-3
5) Sufficient organ function of important organs
Laboratory test results meet the following criteria (within 2 weeks before registration)
a) Hemoglobin: >= 8.0 g/dL
b) WBC: >= 3,000/mm3, <12,000/mm3
c) Neutrophil: >= 1,200/mm3
d) Platelet: >= 100,000/mm3
e) ALT, AST: =< 2.5 x the ULN for the reference lab
f) Total bilirubin: =< 3 x the ULN for the reference lab
g) Creatinine: =< the ULN for the reference lab

Key exclusion criteria

1) Patients with a known allergy or hypersensitivity to any component of levofloxacin.
2) Patient who is unable to comply with dietary restriction*.
*Patients taking prohibited medications and supplements high in metallic cations (e.g. sucralfate, iron pill, milk, yogurt, etc.)
3) Patients who have donated over 200 ml of blood within 2 weeks of therapy.
4) Female patients who are pregnant or breast feeding and women suspected of being pregnant.
5) Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of levofloxacin (e.g. ulcerative disease, malabsorption syndrome or small bowel resection).
6) Participation in a clinical trial within 12 weeks before registration.
7) Patients deemed ineligible by the attending physicians for various reasons.

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukiyoshi Fujita

Organization

Gunma Prefectural Cancer Center

Division name

Department of Pharmacy

Zip code


Address

617-1 Takahayashinishi-cho, Ota, Gunma

TEL

0276-38-0771

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yukiyoshi Fujita

Organization

Gunma Prefectural Cancer Center

Division name

Department of Pharmacy

Zip code


Address

617-1 Takahayashinishi-cho, Ota, Gunma

TEL

0276-38-0771

Homepage URL


Email



Sponsor or person

Institute

Department of Pharmacy, Gunma Prefectural Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Gunma Prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

群馬県立がんセンター(群馬県)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2013 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 08 Month 19 Day

Last modified on

2013 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013465


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name