Trial Outcomes & Findings for Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin (NCT NCT01093690)

NCT ID: NCT01093690

Last Updated: 2010-12-02

Results Overview

number of patients who experience no emesis and need no rescue treatment in 5-day period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 162 participants
• Primary outcome timeframe: 5 days after receiving chemotherapy
• Results posted on: 2010-12-02

Participant Flow

Recruitment period from April 2009-June 2010.

All recruited patients were participate enrollment.

Participant milestones

Measure	Metoclopramide ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5	Placebo ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
Overall Study STARTED	83	79
Overall Study COMPLETED	83	79
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin

Baseline characteristics by cohort

Measure	Metoclopramide n=83 Participants ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5	Placebo n=79 Participants ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5	Total n=162 Participants Total of all reporting groups
Age, Customized Between 18 and 50 years	41 participants n=5 Participants	38 participants n=7 Participants	79 participants n=5 Participants
Age, Customized >= 50 years	42 participants n=5 Participants	41 participants n=7 Participants	83 participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Region of Enrollment Thailand	83 participants n=5 Participants	79 participants n=7 Participants	162 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days after receiving chemotherapy

Population: intention to treat

number of patients who experience no emesis and need no rescue treatment in 5-day period

Outcome measures

Measure	Metoclopramide n=83 Participants ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5	Placebo n=79 Participants ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
Number of Patients Who Had Complete Response	50 participants	42 participants

SECONDARY outcome

Timeframe: 5 days after receiving chemotherapy

Outcome measures

Outcome data not reported

Adverse Events

Metoclopramide

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metoclopramide n=83 participants at risk ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5	Placebo n=79 participants at risk ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
General disorders fatigue	49.4% 41/83 • Number of events 41	54.4% 43/79 • Number of events 43
General disorders anorexia	47.0% 39/83 • Number of events 39	58.2% 46/79 • Number of events 46
General disorders headache	6.0% 5/83 • Number of events 5	12.7% 10/79 • Number of events 10
Gastrointestinal disorders constipation	45.8% 38/83 • Number of events 38	36.7% 29/79 • Number of events 29
General disorders sleepiness	12.0% 10/83 • Number of events 10	8.9% 7/79 • Number of events 7
General disorders hiccup	8.4% 7/83 • Number of events 7	7.6% 6/79 • Number of events 6

Additional Information

Suthinee Ithimakin, MD

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Phone: 6624197000

Email: aesi105@yahoo.co.th

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place