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Registerhigh dropout for vomiting [Study Assessment]
Hi All,
Our CRO just dosed the drug for fed and fasting BE study. This drug is for rare disease, causing 1/3 of patients vomit in literature. The calculated sample size is 35 sub for each condition, and we added up to 51 for 3 way. Now for the Period I, 19 and 31 subjects could not continue because of vomiting.
I back to check the literature, one research BE paper in fed condition, 24 sub enrolled, and 17 completed for 2 way and the drug still passed (intra CV is ~20%).
This the first time I have such tough drug. CRO gave several choices：
1。The CRO suggests Ondacetron could be used anti-vomiting.
2. Start over with more subjects
3. continue the current trials
Any suggestion for the tough one?
Thank you very much
Edit: Category changed. [Helmut]
Our CRO just dosed the drug for fed and fasting BE study. This drug is for rare disease, causing 1/3 of patients vomit in literature. The calculated sample size is 35 sub for each condition, and we added up to 51 for 3 way. Now for the Period I, 19 and 31 subjects could not continue because of vomiting.
I back to check the literature, one research BE paper in fed condition, 24 sub enrolled, and 17 completed for 2 way and the drug still passed (intra CV is ~20%).
This the first time I have such tough drug. CRO gave several choices：
1。The CRO suggests Ondacetron could be used anti-vomiting.
2. Start over with more subjects
3. continue the current trials
Any suggestion for the tough one?
Thank you very much
Edit: Category changed. [Helmut]
Complete thread:
- high dropout for vomitingzheng791 2013-09-26 16:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- high dropout for vomiting Dr_Dan 2013-09-27 09:59
Ing. Helmut Schütz