UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015213
Receipt number R000017690
Scientific Title A novel treatment for persistent intractable hiccups : Continuous cervical epidural block
Date of disclosure of the study information 2014/09/21
Last modified on 2014/09/20 14:51:12

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Basic information

Public title

A novel treatment for persistent intractable hiccups : Continuous cervical epidural block

Acronym

A novel treatment for persistent intractable hiccups : Continuous cervical epidural block

Scientific Title

A novel treatment for persistent intractable hiccups : Continuous cervical epidural block

Scientific Title:Acronym

A novel treatment for persistent intractable hiccups : Continuous cervical epidural block

Region

Asia(except Japan)


Condition

Condition

Persistent intractable hiccup

Classification by specialty

Medicine in general Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine whether continuous cervical epidural block is effective for persistent intractable hiccups

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Remission rate of persistent intractable hiccups

Key secondary outcomes

Time needed for remission, Adverse effects, Recurrence rate


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 Device,equipment

Interventions/Control_1

continuous cervical epidural block :
continuous infusion of 4 mL/h of 0.123% ropivacaine with or without daily 6ml bolus of 0.25% ropivacaine

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

19 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Persistent hiccup bouts lasting more than 48 hours
and
2) Intractable hiccups with which medical treatments failed before

Key exclusion criteria

1) For those suffering inflammation
2) For those having bleeding tendency or undertaking anti-coagulation or anti-platelet therapy
3) For those suffering psychiatric disorder
4) Pregnant or Lactating women
5) For those who have history of cardiac infarction in the last three months, or suffering angina pectoralis
6) For those having history of Idiopathic pulmonary fibrosis or interstitial pneumonia

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sang Sik Choi

Organization

Korea University Guro Hospital

Division name

Anesthesiology and pain medicine

Zip code


Address

Korea University Guro Hospital, Guro 2-dong, Guro-gu, Seoul, Republic of Korea 152-703

TEL

+82-2-2626-1870

Email

clonidine@empas.com


Public contact

Name of contact person

1st name
Middle name
Last name Jung eun Kim

Organization

Korea University Guro Hospital

Division name

Anesthesiology and pain medicine

Zip code


Address

Korea University Guro Hospital, Guro 2-dong, Guro-gu, Seoul, Republic of Korea 152-703

TEL

+82-2-2626-1870

Homepage URL


Email

geri200@gmail.com


Sponsor or person

Institute

Korea University, Guro Hospital, Department of Anesthesiology and pain medicine

Institute

Department

Personal name



Funding Source

Organization

Korea University, Guro Hospital

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

2014 Year 09 Month 21 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

2006 Year 02 Month 16 Day

Date of IRB


Anticipated trial start date

2006 Year 02 Month 16 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

2014 Year 09 Month 20 Day

Last modified on

2014 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name