Evaluation of an Adaptive Maximizing Design Study Based on Clinical Utility Versus Morphine for TRV130 Proof-ofConcept and Dose-Regimen Finding in Patients With Postoperative Pain After Bunionectomy

Conventional opioids provide powerful analgesia but also produce efficacy-limiting adverse effects, limiting their clinical utility (CU). TRV I 30 is being evaluated to determine whether CU can be expanded by way of increased efficacy, decreased adverse effects, or some combination thereof. This pha...

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Bibliographic Details
Published in:Therapeutic innovation & regulatory science 2015-09, Vol.49 (5), p.756-756
Main Authors: Bolognese, James A, Subach, Ruth Ann, Skobieranda, Franck
Format: Article
Language:English
Subjects:
Analgesics
Clinical trials
Pain management
Studies
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Summary:Conventional opioids provide powerful analgesia but also produce efficacy-limiting adverse effects, limiting their clinical utility (CU). TRV I 30 is being evaluated to determine whether CU can be expanded by way of increased efficacy, decreased adverse effects, or some combination thereof. This phase 2 study of TRY I 30 blends traditional objectives with novel design features aimed toward the specific strategic goal of optimizing the attributes of TRV I 30 efficacy and tolerability compared with the conventional opioid, morphine. The adaptive maximizing design (AMD) was developed to maximize assignment of future patients to doses that demonstrate maximum balance between efficacy and tolerability assessed via a CU function. The evaluation of the AMD performance characteristics reveals that the AMD has a strong capacity to estimate the TRV I 30 dose-regimens with maximum CU, assign more patients to the TRY I 30 dose-regimens with maximum CU, and, conversely, assign fewer patients to doses away from the those with maximum or near-maximum CU.
ISSN:2168-4790
2168-4804