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shorts-soiling
pay for performance
Jul 12, 2010 06:30
13 yrs ago
12 viewers *
English term

multiple dose

English Medical Medical (general) RA
A randomised, double blind, placebo-controlled, multiple dose trial ....
[does it mean that 1) different patients (treatment groups) receive different doses of study drug or 2) that the same patient receive many times the same dose?]
Responses
4 +3 multiple doses administered to the same patient
4 +2 several doses are given to each patient
References
Support of 'multiple doses' to a trial group (multiple persons)

Discussion

MMUlr Jul 13, 2010:
Let me add a note ... To me it was perfectly clear that we are talking about a clinical trial with "multiple patients" - the question is (really dependent on the trial design) if the escalating doses are administered to a patient group one after the other (-> e.g., 2 weeks dose A, 2 weeks dose B, etc.) OR if the design separates patient groups just from the beginning (see the URL in my answer box).

Occasionally I found also "multiple dose" in order to differentiate from "single dose" study, Studie mit Einmaldosierung vs. Studie mit Mehrfachdosierung, e.g. this one: http://aac.asm.org/cgi/reprint/34/2/202.pdf - Subjects receive only one single dose of various dosages (in separate groups).
kmtext Jul 12, 2010:
Hard to say It's possible that the patients receive multiple doses of one concentration or multiples of a number of concentrations. It's hard to say which this is without more context. However, the implication is that there are a number of patients involved in the study.

Responses

+3
17 mins
Selected

multiple doses administered to the same patient

... during the course of trial, in contrast to single-dose trial (mostly for pharmacokinetic studies).



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Note added at 22 mins (2010-07-12 06:52:42 GMT)
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sorry, let me add this:
IMO there are multiple dose levels tested - e.g., in this trial:
http://clinicaltrials.gov/ct2/results?term=Study of the Effi...

See table showing the different trial arms!

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Note added at 24 mins (2010-07-12 06:54:08 GMT)
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So your option no. 1 - different patients (usually!) in different dose groups.
Peer comment(s):
agree Demi Ebrite
20 mins
Thank you, Demi.
agree Filippe Vasconcellos de Freitas Guimarães
4 hrs
Thank you, fvasconcellos.
agree Lynda Bogdan (X)
2 days 17 hrs
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Selected automatically based on peer agreement."
+2
26 mins

several doses are given to each patient

Several doses of the medication are given to each of the patients, as opposed to single dose where only one dose would be administered to the patient.

"48 subjects, divided into 6 groups and randomized in a 3:1 ratio for active treatment and placebo, received multiple oral doses of 50, 100, 150 or 200 mg PLD-118 q8h, as well as 150 or 300 mg q12h. Each volunteer received a single dose on the first day, followed by a 72 h wash out period, multiple doses for 7 days, and a single dose on the last dosing day. "
Reference:

http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102267831.html

Peer comment(s):
neutral MMUlr : also possible, but you can find different study designs / protocols, so it will definitely depend on the specific trial in question.
4 mins
There would have to be more than one patient in the trial, surely...
agree Carolyn Gille : although both answer seem correct to me, this one includes the idea that there are also 'multiple' patients (as in the source text)
5 mins
Thanks Carolyn!
agree Filippe Vasconcellos de Freitas Guimarães : I'm with Carolyn. Multiple patients (otherwise it's not a trial!) given various doses of the same drug, e.g. 20, 40, 60, 80, 100 mg. A common design for tolerability trials.
4 hrs
Thanks, that's what I thought as well.
Something went wrong...

Reference comments

1 hr
Reference:

Support of 'multiple doses' to a trial group (multiple persons)

The study sited in the first reference URL is a clear example of a "randomised, double blind, placebo-controlled, multiple dose trial" performed by Gilead Sciences.

The second URL provides a list of many trials found using the search words: randomised, double blind, placebo-controlled, multiple dose trial on the Clinicaltrials.gov site, a service of the U.S. National Institutes of Health.
Reference:

http://clinicaltrials.gov/ct2/show/NCT00999531

http://clinicaltrials.gov/ct2/results?term=randomised%2C+double+blind%2C+placebo-controlled%2C+multiple+dose+trial

Peer comments on this reference comment:
agree Filippe Vasconcellos de Freitas Guimarães : That study arms table certainly puts the "multiple dose" in "multiple-dose trial" :)
4 hrs
That it does! Thank you, fvasconcellos.
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