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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Chung-Ang University
Sponsor:
Collaborators:
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University
ClinicalTrials.gov Identifier:
NCT01974024
First received: October 28, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01974024

Contacts
Contact: Jung Hun Kang, M.D. 82-10-9344-0543 newatp@gnu.ac.kr
Contact: In Gyu Hwang, M.D. 82-10-3566-9053 hematoonco@naver.com

Locations
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    hematoonco@naver.com   
Principal Investigator: In Gyu Hwang, M.D.         
Sponsors and Collaborators
Chung-Ang University
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Investigators
Study Chair: Jung Hun Kang, M.D. Gyeongsang National University Hospital
  More Information

No publications provided

Responsible Party: In Gyu Hwang, In Gyu Hwang/Associate Professor, Chung-Ang University
ClinicalTrials.gov 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:
Dexamethasone
Hiccup
Chemotherapy
Methylprednisolone

Additional relevant MeSH terms:
Hiccup
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014