A double-blind randomized controlled trial comparing 3mg and 1mg of ranisetron for the control of chemotherapy-induced acute emesis

UMIN ID: UMIN000000984

Registered date:19/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant tumor (breast cancer, lung cancer, gastric cancer, esophagus cancer, colorectal cancer, etc)
• Date of first enrollment: 2008/01/01
• Target sample size: 360
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Granisetron 3mg + dexamethasone (drip infusion)
Granisetron 1mg + dexamethasone (drip infusion)

Outcome(s)

• Primary Outcome: complete protection from vomiting within 24 hours
• Secondary Outcome: 1) Degree of nausea within 24 hours 2) Time to vomiting expression within 24 hours 3)The number of vomiting 4)Degree of nausea in the delayed phase 5)The change of the stool frequency

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1)patients with history of hypersensitivity to 5-HT3 receptor antagonist and corticosteroids (2)patient who do not have enough whole body state to the antineoplastic agents treatment (3)pregnant or expecting woman (4)patient who enforces radiotherapy in the abdomen on the day of chemotherapy (5)uncontrollable diabetes mellitus (6)hepatitis B or C virus Carrier (7)patients having a clear vomiting symptom such as brain metastasis or obstruction to the passage of foods (8)the patient who judged inappropriate as an object of this study

Related Information

• Primary Sponsor: Pharma Valley Center, Shizuoka Organization for Creation Industries
• Source(s) of Monetary Support: Pharma Valley Center, Shizuoka Organization for Creation Industries