UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001573 |
|---|---|
| Receipt number | R000001897 |
| Scientific Title | Effects of baclofen on body weight in obese patients |
| Date of disclosure of the study information | 2008/12/15 |
| Last modified on | 2012/06/13 10:06:00 |
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Basic information
Public title
Effects of baclofen on body weight in obese patients
Acronym
Effects of baclofen on obesity
Scientific Title
Effects of baclofen on body weight in obese patients
Scientific Title:Acronym
Effects of baclofen on obesity
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether baclofen could reduce body weight in obese patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
body weight, waist size
Key secondary outcomes
parameters related to glucose and lipid metabolism, blood pressure, appetite
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All patients will be administered baclofen (three times a day) for 12 weeks. The amount of baclofen is 15 mg/day for day1-3, 20 mg/day for day 4-6, 25 mg/day for day 7-9, and 30 mg/day for day 10-84, unless there are side effects such as sleepness, muscular weakness, nausea and anorexia.
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
BMI: 30 or more
Key exclusion criteria
patients with renal failure (Cr 1.5 mg/dl or more), insulin therapy, pregnancy or possible pregnancy, epilepsy (including its past history), mental diseases, ulcer or respiratoy failure
patients who have been taking sleeping pills
patients who the doctor judges should not be involved in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2142
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2142
Homepage URL
arima105@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2008 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Baclofen significantly reduced BW and waist circumference in obese subjects.
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
| 2008 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 13 | Day |
Last modified on
| 2012 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001897
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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