drugset / Trial / NCT01119222

Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers

NCT01119222

Phase 1 Completed 19 enrolled Pfizer
RandomizedCrossoverDouble-blind

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.

Timeline

Start
2008-07
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diphenhydramine Unknown 50 mg
Comparator Gabapentin Small molecule 1200 mg
Comparator Morphine Other / unclassified 10 mg Intravenous

Indications

No indication recorded.