UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001216
Receipt number 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 23:34:37

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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 or person

Institute

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

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


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

Value
https://center6.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