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Randomize Controlled Phase 3, Cross-over Trial of Dexamethasone-induced Hiccup in Chemotherapy Patients Treated by Methylprednisolone Rotation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2013 by Chung-Ang University.
Recruitment status was  Not yet recruiting
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University Identifier:
First received: October 28, 2013
Last updated: October 31, 2013
Last verified: October 2013
The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH

Condition Intervention Phase
Dexamethasone-induced Hiccup in Chemotherapy
Drug: methylprednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Chung-Ang University:

Primary Outcome Measures:
  • The intensities of hiccups [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.

Secondary Outcome Measures:
  • The intensities of emesis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    CLinically assessed every cycles (2-4weeks) The intensities of emesis were assessed using a NRS.

Estimated Enrollment: 140
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylprednisolone
Dexamethasone was replaced with methylprednisolone as an antiemetic
Drug: methylprednisolone
Active Comparator: Dexamethasone
Dexamethasone was re-administered in the cycle
Drug: methylprednisolone


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all solid cancer patients on chemotherapy
  • age >18 years
  • received dexamethasone as an antiemetic

Exclusion Criteria:

  • brain metastases
  • hiccups before dexamethasone administration
  • uncontrolled diabetes mellitus
  • uncontrolled esophagitis or peptic ulcer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01974024

Contact: Jung Hun Kang, M.D. 82-10-9344-0543
Contact: In Gyu Hwang, M.D. 82-10-3566-9053

Korea, Republic of
Gyeongsang National University Hospital Active, not recruiting
Chiram-dong, Jinju-si, Gyeongsangnam-do, Korea, Republic of, 660-702
Chungang University Hospital Not yet recruiting
Dongjak-gu, Seoul, Korea, Republic of, 156-755
Contact: In Gyu Hwang, M.D.    +82-10-3566-9053   
Principal Investigator: In Gyu Hwang, M.D.         
Sponsors and Collaborators
Chung-Ang University
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Study Chair: Jung Hun Kang, M.D. Gyeongsang National University Hospital
  More Information

Responsible Party: In Gyu Hwang, In Gyu Hwang/Associate Professor, Chung-Ang University Identifier: NCT01974024     History of Changes
Other Study ID Numbers: GSNUH 2013-1 
Study First Received: October 28, 2013
Last Updated: October 31, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chung-Ang University:

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on May 03, 2016