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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011518
Receipt No. 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

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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 Obsterics 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
Institute Department of Pharmacy, Gunma Prefectural Cancer Center
Institute
Department

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
URL(English) https://upload.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


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