UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032110 |
|---|---|
| Receipt number | R000036632 |
| Scientific Title | Effect of Risedronate Sodium on Nausea and Vomiting Caused by Heavy Exercise |
| Date of disclosure of the study information | 2018/04/05 |
| Last modified on | 2019/02/19 23:20:30 |
* 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
Effect of Risedronate Sodium on Nausea and Vomiting Caused by Heavy Exercise
Acronym
Effect of Risedronate Sodium on Nausea and Vomiting Caused by Heavy Exercise
Scientific Title
Effect of Risedronate Sodium on Nausea and Vomiting Caused by Heavy Exercise
Scientific Title:Acronym
Effect of Risedronate Sodium on Nausea and Vomiting Caused by Heavy Exercise
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of risedronate sodium on nausea and vomiting caused by heavy exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The degree of nausea and vomiting during- or post-exercise
Key secondary outcomes
- Post-exercise blood calcium, serum TRACP-5b levels, and eGFR
- The degree of clinical symptoms of heatstroke
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Pre-exercise oral medication of Risedronate sodium (3 & 10 days before exercise)
Interventions/Control_2
Pre-exercise oral medication of Placebo (3 & 10 days before exercise)
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Japan Self-Defense Force Members in the Airborne Ranger Training Course
Key exclusion criteria
- Members contraindicated for Risedronate sodium
- Members who are considered inappropriate for this trial by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Senda |
Organization
Self-Defense Forces Central Hospital
Division name
Department of diagnosis and treatment
Zip code
Address
Ikejiri 1-2-24, Setagaya-ku, Tokyo
TEL
03-3411-0151
senda-m@olive.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Okuyama |
Organization
Self-Defense Forces Central Hospital
Division name
Department of research
Zip code
Address
Ikejiri 1-2-24, Setagaya-ku, Tokyo
TEL
03-3411-0151
Homepage URL
research4-c-hosp@inet.gsdf.mod.go.jp
Sponsor or person
Institute
Self-Defense Forces Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-Defense Forces Central Hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University
Name of secondary funder(s)
Osaka University
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
| 2018 | Year | 04 | Month | 05 | 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
| 2018 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | 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
| 2018 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
