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In the COMACS study children were assigned to dosing strata on the basis of pre-trial dose levels.
However, the transfer from pre-trial dose to baseline dose was performed differently than in the current trial.
1. Active medicine a. MPH - maximum dose 0.3 mg/kg a. MPH – long acting tablets (on pre-trial dose) OR a. DEX - maximum dose 0.15 mg/kg/DOSE 2. Placebo - visually matched capsule at the same dose as test medicine.
Subjects were instructed to self-titrate in accordance with their respective algorithms and continue with their pre-trial metformin dose.
Participants were to continue on an equivalent dose of IAsp to their pre-trial mealtime insulin dose.
The small imbalance in starting doses in that trial was not observed in the current trial where pre-trial basal insulin doses were switched on a 1 : 1 basis for both IDeg and IDet.
Because of limited efficacy data for single dose dexketoprofen and tramadol at the doses envisaged, the pre-trial estimates could be little more than informed guesses, but they were not inaccurate.
This is consistent with the findings of the VA/NIH group in their pre-trial survey that assessment of the delivered dose of IRRT was performed infrequently in clinical practice [ 13].
The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae.
During this trial, pre-dose MPA levels were obtained from patients achieving stable maintenance doses of study drug.
Four to six hours pre-trial, we injected females with a compound of progesterone and peanut oil (10 mg/ml) at a dose of 1 ml/100 g of body weight.
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