Study on Analgesia of GIC-1001 & GIC-1002 on Visceral Pain, Rectal Sensory Threshold Using the Barostat Method
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This study evaluates colonic analgesia by comparing two novel formulations, GIC-1001 and
GIC-1002 with placebo using a barostat distender. The healthy male and female volunteers
randomized to one of 5 possible treatments will be exposed to rectal distension following a
3-day treatment TID. The barostat methodology is a well-established and validated way to
assess visceral pain. Visceral pain will be evaluated during exposure to varying distender
pressures using a visual analog scale.