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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001216
Receipt No. R000001484
Scientific Title A study of the effect of nicergoline for dysphagia in patients with aspiration pneumonia
Date of disclosure of the study information 2009/01/01
Last modified on 2011/07/13

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Basic information
Public title A study of the effect of nicergoline for dysphagia in patients with aspiration pneumonia
Acronym The effect of nicergoline in dysphagia
Scientific Title A study of the effect of nicergoline for dysphagia in patients with aspiration pneumonia
Scientific Title:Acronym The effect of nicergoline in dysphagia
Region
Japan

Condition
Condition Dysphagia
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of nicergoline for dysphagia in patients with aspiration pneumonia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Swallowing reflex
Serum level of substance P
Key secondary outcomes Recurrence of aspiration pneumonia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment by nicergoline
Interventions/Control_2 Treatment by imidapril
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Dysphagia patients proved by simple swallowing provocation test.
Patients with past history of pneumonia.
Patients who have signed the agreement for participation in this study.
Key exclusion criteria Patients who have already taken nicergoline or imidapuril.
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Nakashima
Organization Hiroshima General Hospital of West Japan Railway Company
Division name Department of respiratory disease
Zip code
Address 3-1-36 Futabanosato, Higashi-ku, Hiroshima-city 732-0057 Japan
TEL 082-262-1171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Taku Nakashima
Organization Hiroshima General Hospital of West Japan Railway Company
Division name Department of respiratory disease
Zip code
Address 3-1-36 Futabanosato, Higashi-ku, Hiroshima-city 732-0057 Japan
TEL 082-262-1171
Homepage URL
Email

Sponsor
Institute Department of respiratory disease, Hiroshima General Hospital of West Japan Railway Company
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21694649
Number of participants that the trial has enrolled
Results -Significant elevations of serum substance P were obtained by both medications (nicergoline or imidapril) after 4 weeks of treatment.
-Patients whose dysphagia was improved showed significantly increased serum levels of substance P.
-There was no statistically significant difference in the overall proportion of patients who showed improvements in dysphagia and pneumonia recurrence with imidapril or nicergoline treatment.
-Nicergoline, but not imidapril, seemed to be more effective at improving dysphagia and elevating serum substance P in patients with dementia.
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 06 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 08 Month 01 Day
Date analysis concluded
2009 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 27 Day
Last modified on
2011 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001484

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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