Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

621

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Colon CancerColorectal CarcinomaColon Cleansing
Interventions
DRUG

NER1006

The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.

DRUG

Trisulfate solution

The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.

Trial Locations (12)

11023

Long Island Gastrointestinal Research Group, LLP, Great Neck

20815

MGG Group Co., Inc., Chevy Chase Clinical, Chevy Chase

21401

Investigative Clinical Research, Annapolis

24803

Trial Management Associates, LLC, Wilmington

27262

Peters Medical Research, High Point

27612

Wake Research Associates, LLC, Raleigh

28304

Cumberland Research Associates, LLC, Fayetteville

44060

Investigative Clinical Research, LLC, Mentor

45219

Consultants for Clinical Research, Cincinnati

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

84405

Advanced Research Institute, Ogden

92801

Anaheim Clinical Trials, Anaheim

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Norgine

INDUSTRY

NCT02254486 - Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults | Biotech Hunter | Biotech Hunter