UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021424 |
|---|---|
| Receipt number | R000024689 |
| Scientific Title | Efficacy of oral citrate for muscle cramps due to imatinib |
| Date of disclosure of the study information | 2016/03/10 |
| Last modified on | 2016/03/10 17:54:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of oral citrate for muscle cramps due to imatinib
Acronym
Efficacy of oral citrate for muscle cramps due to imatinib
Scientific Title
Efficacy of oral citrate for muscle cramps due to imatinib
Scientific Title:Acronym
Efficacy of oral citrate for muscle cramps due to imatinib
Region
| Japan |
Condition
Condition
chronic myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of oral citrate for muscle cramps due to imatinib in patients with chronic myeloid leukemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of muscle cramps in three months with or without oral citrate
Key secondary outcomes
adverse event
location of muscle cramps
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
three-month observation and then administration of oral citrate for three months
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have chronic myeloid leukemia.
2. Patients who are given imatinib mesylate at a daily dose of 300 - 400 mg for more than 6 months.
3. Patients who had muscle cramps more than eight times in three months.
4. Patients who go to Devision of hematology, Keio University Hospital.
5. Patients who agreed to participate this clinical trial, and signed to informed consent form.
Key exclusion criteria
1. Patient who have severe renal impairment
2. Patients who take drugs inducing muscle cramps , such as statin, diuretic, analgesic, steroid, cyclosporine, vincristine or cisplatin, etc.
3. Patients who have diseases accompanied by muscle cramps, such as liver chirosis or diabetes mellitus, etc.
4. Patients who take drugs preventing or treating muscle cramps.
5. Patients who are considered as inappropriate to register by attending physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kato |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
j-kato@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kato |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
j-kato@z8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 10 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 20 | 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
| 2016 | Year | 03 | Month | 10 | Day |
Last modified on
| 2016 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024689
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
