Phase Ib pain trials

Phase I mechanism based proof-of-concept experimental pain studies. The C4Pain strategy is to obtain drug efficacy data from human volunteers as early as possible in the drug development phase utilising human pain bio-markers and surrogate pain models to qualify go/no-go decisions as early as possible and to qualify the selection of the patient population (sub-population) which is most likely to respond to the compound. Such studies can be done for single dose, multiple dosing or in dose escalation studies. Adding experimental pain measures in early studies are for free at they can be done in addition to pharmacokinetic sampling and side-effect profiling. 

 

The C4Pain strategy is to obtain drug efficacy data from patients as early as possible in the drug development phase utilising human pain bio-markers together with clinical measures to qualify go/no-go decisions as early as possible. Such studies can be done for single dose, multiple dosing or in dose escalation studies. Adding experimental pain measures in early studies are for free at they can be done in addition to pharmacokinetic sampling and side-effect profiling.

 

Phase II pain trials

The C4Pain strategy is to obtain pain mechanism related date from patients using pain bio-marker together with clinical measures to qualify go/no-go decisions and to be optimally qualified for selecting patients for later clinical trials, i.e selecting the most optimal primary outcome parameters. Such studies can be done for single dose, multiple dosing or in dose escalation studies. Adding experimental pain measures to selected well caracterised patients will provide information on which important pain mechanisms are modulated. 

 

Phase III and IV pain trials

C4Pain has the capability to perform large phase III and phase IV trials including extensions of phase II trials in order to meet what ever regulatory requests from the FDA or EMEA concerning efficacy and safety and in the future which pain mechanisms are involved. From a mechanism based perspective it is an advantage to include pain bio-markers in clinical studies together with the traditional clinical pain scores as such measures often are more sensitive than simple clinical pain measures and provide a valuable additional mechanistic understanding of the drug action.

 

Trial design and interpretation

Although pre-clinical data on drug efficacy only sparsely resemble the effects in pain patients C4Pain use the available data to design human proof-of-concept studies (forward-translation) and may suggest clients to acquire additional pre-clinical information (back-translation). The C4Pain research based approach may suggest back-translation of human pain bio-markers to closer mimic the pre-clinical models to the human conditions. If needed C4Pain develops and validates new human pain bio-markers.

 

 C4Pain constantly enlarge its library of already mechanism based profiled compounds and hence new compounds within the same class of already profiled compounds provides valuable insight into which human pain bio-markers may be the most sensitive. This significantly enhances the chances for success when trials are designed and bio-markers and clinical pain parameters are selected. No other CRO in the world has such a comprehensive service to offer. This knowledge is applied in design and protocol development. After trial completion C4Pain offers state-of-the art interpretation of the results.

C4Pain ApS, Hobrovej 42 D 9000 Aalborg, Denmark. info@C4pain.com

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