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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: A Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 (a Low Volume Bowel Cleansing Solution) Versus a Trisulfate Bowel Cleansing Solution Using 2-Day Split-Dosing Regimen in Adults

Study ID: NCT02254486

Study Description

Brief Summary: This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 2 groups.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Anaheim Clinical Trials, Anaheim, California, United States

Investigative Clinical Research, Annapolis, Maryland, United States

MGG Group Co., Inc., Chevy Chase Clinical, Chevy Chase, Maryland, United States

Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, United States

Long Island Gastrointestinal Research Group, LLP, Great Neck, New York, United States

Cumberland Research Associates, LLC, Fayetteville, North Carolina, United States

Peters Medical Research, High Point, North Carolina, United States

Wake Research Associates, LLC, Raleigh, North Carolina, United States

Trial Management Associates, LLC, Wilmington, North Carolina, United States

Consultants for Clinical Research, Cincinnati, Ohio, United States

Investigative Clinical Research, LLC, Mentor, Ohio, United States

Advanced Research Institute, Ogden, Utah, United States

Contact Details

Name: Michael Demicco

Affiliation: Anaheim Clinical Trials, CA

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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