Study on Analgesia of GIC-1001 & GIC-1002 on Visceral Pain, Rectal Sensory Threshold Using the Barostat Method

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
PainCancerColonic Disease
Interventions
DRUG

GIC-1001 375 mg TID

GIC-1001 375 mg TID mid-dose, oral tablet, white-coated, to be taken with water

DRUG

GIC-1001 500 mg TID

GIC-1001 500 mg TID high-dose, oral tablet, white-coated, to be taken with water

DRUG

GIC-1002 345 mg TID (equimolar to GIC-1001 375 mg TID)

GIC-1002 345 mg TID mid-dose, oral tablet, white-coated, to be taken with water

DRUG

GIC-1002 460 mg (equimolar to GIC-1001 500 mg)

GIC-1002 460 mg TID high-dose, oral tablet, white-coated, to be taken with water

OTHER

Placebo

Placebo identical and matching active drugs GIC-1001 and GIC-1001

Trial Locations (1)

H3P-3P1

Algorithme Pharma Inc., Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Algorithme Pharma Inc

INDUSTRY

lead

gicare Pharma Inc.

INDUSTRY