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

NCT02276768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-08-10

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Algorithme Pharma Inc

    collaborator INDUSTRY

  • gicare Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, M.D. · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02276768 on ClinicalTrials.gov