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  • hwsimpsonshero hwsimpsonshero Sep 13, 2013 11:06 AM Flag

    Phase 2 Trial Design. Accounting for Dropouts -- Rescue Medication.

    Like a few others have posted in the past few days, my biggest concern with Z-160 is the dropout rate, particularly with the placebo group in the LSR trial. One poster astutely pointed out that patients enrolling in this trial are likely patients who very specifically don't want to take opiods. Thus, they are more likely to complete the trial. I agree with that, but even so, pain is pain.

    There's no doubt that a significant number of the placebo LSR patients would not be able to live with pain for 6 entire weeks. So I've been worried about how the trial will account for this. I went onto the clinicaltrials website to do some digging. I discovered that patients in the trial are allowed to take rescue medications. A rescue medication is a quick-relief or fast-acting medication patients in clinical trials may be given besides the investigational drug or control that can alleviate symptoms due to disease or lack of efficacy of the study treatment. It acts quickly to stop symptoms, but the effects are not long lasting.

    On top of that, the use of rescue medications is one of the secondary endpoints. Pretty safe to assume the placebo group will be using these meds heavily and thusly, this should reduce the dropout rate quite a bit. Another pertinent point is that patients cannot test positive for drug use, and alcoholics are excluded. So in other words, the only medication that could be used for pain relief would be the rescue medication.

    Feeling a little more confident after learning about all of this.

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