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Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients


N/A
21 Years
70 Years
Not Enrolling
Both
Dexamethasone, Hiccup

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Trial Information

Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients


Inclusion Criteria:



- Age olderthan 21

- A Patient on chemotherapy who was diagnosed malignant tumor

- A Patient who is newly developed hiccup in the course of chemotherapy

- A patient with the willingness to comply with the study protocol during the study
period and capable of ccomplying with it

- A patient who signed the imformed consent prior to the participation of the study and
who understands that he/she has a right to withdrawal from participation in the study
at any time without any disadvantages

Exclusion Criteria:

- A patient with history of uncontrolled seizures, central nervous system disorder or
psychiatric disorders that are considered clinically significant by the investigator
that would prohibit the understanding of informed consent or that may be considered
to interfere with the compliance of the administration of the study medications

- A patient with uncontrolled diabetes

- A patient who developed uncontrolled serious infection or other uncontrolled serious
concomitant diseases

- A patient with disease progression after run-in period who is expected to receive
another chomotherapeutic agents with different level of emetic risk

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prevention rate of dexamethasone induced hiccup

Outcome Description:

measure the presence of hiccup and its severity 24 hous after chemotherapy

Outcome Time Frame:

24hrs after chemotherapy

Safety Issue:

Yes

Principal Investigator

Jung Hun Kang, M.D, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gyeongsang University Hospital

Authority:

South Korea: Institutional Review Board

Study ID:

Gyeongsang-20100701

NCT ID:

NCT01277731

Start Date:

July 2010

Completion Date:

December 2011

Related Keywords:

  • Dexamethasone
  • Hiccup
  • Hiccup

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