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Methylprednisolone Replacement for Dexamethasone-induced Hiccup

Information source: Gyeongsang National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dexamethasone; Hiccup

Intervention: Methylprednisolone (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Gyeongsang National University Hospital

Official(s) and/or principal investigator(s):
Jung Hun Kang, M.D, Ph.D, Principal Investigator, Affiliation: Gyeongsang University Hospital

Summary

Dexamethasone is a potent synthetic member of the corticosteroid. It is given to cancer patients undergoing chemotherapy to counteract emetic side effect and essential drug for the chemotherapy-treated patients. Hiccup is common adverse effect of corticosteroid especially on dexamethasone varying from 3% to 60% of given patients. Discontinuance of dexamethasone relieves most hiccupping cases, but vomiting/nausea rates increase. It is not clear whether hiccup side effect is limited to the dexamethasone only or other corticosteroid group. Methylprednisolone, synthetic corticosteroid as similar as dexamethasone, could be considered as antiemetic agent for the patients with receiving chemotherapy. The investigators perform this pilot study under hypothesis that replacing dexamethasone with methylprednisolone could maintain antiemetic role and prevent hiccup.

Clinical Details

Official title: Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients

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

Primary outcome: Prevention rate of dexamethasone induced hiccup

Secondary outcome: Prevention rate of nausea and vomiting

Eligibility

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Gyeongsang University Hospital, Jinju, Korea, Republic of
Additional Information

Starting date: July 2010
Last updated: November 18, 2012

Page last updated: August 23, 2015

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