At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-Blind, Double-Dummy, Placebo And Active Controlled, 4-Way Crossover Methodology Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating Gabapentin, Diphenhydramine, and 2 other interventions for Healthy. Completed, enrolled 19 participants across 1 site.
Detailed Summary
Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.
Study Details
Timeline
Interventions
Capsule, single 1200mg dose
Tablet, single 50mg dose
IV, single 10mg dose
Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).