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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02254486

Public ClinicalTrials.gov record NCT02254486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02254486
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Norgine
Industry
Enrollment
621 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2014 (Actual)
Primary completion
Jun 2015 (Actual)
Completion
Jun 2015 (Actual)
Last update posted
May 15, 2018

2014 – 2015

United States locations

U.S. sites
12
U.S. states
7
U.S. cities
12
Facility City State ZIP Site status
Anaheim Clinical Trials Anaheim California 92801 —
Investigative Clinical Research Annapolis Maryland 21401 —
MGG Group Co., Inc., Chevy Chase Clinical Chevy Chase Maryland 20815 —
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047 —
Long Island Gastrointestinal Research Group, LLP Great Neck New York 11023 —
Cumberland Research Associates, LLC Fayetteville North Carolina 28304 —
Peters Medical Research High Point North Carolina 27262 —
Wake Research Associates, LLC Raleigh North Carolina 27612 —
Trial Management Associates, LLC Wilmington North Carolina 24803 —
Consultants for Clinical Research Cincinnati Ohio 45219 —
Investigative Clinical Research, LLC Mentor Ohio 44060 —
Advanced Research Institute Ogden Utah 84405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02254486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 15, 2018 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02254486 live on ClinicalTrials.gov.

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