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COMPLETED Phase 3

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

NCT02254486 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG NER1006
  • DRUG Trisulfate solution

Study Locations (12)

North Carolina

  • Cumberland Research Associates, LLC — Fayetteville
  • Peters Medical Research — High Point
  • Wake Research Associates, LLC — Raleigh
  • Trial Management Associates, LLC — Wilmington

Maryland

  • Investigative Clinical Research — Annapolis
  • MGG Group Co., Inc., Chevy Chase Clinical — Chevy Chase

Ohio

  • Consultants for Clinical Research — Cincinnati
  • Investigative Clinical Research, LLC — Mentor

California

  • Anaheim Clinical Trials — Anaheim

Michigan

  • Clinical Research Institute of Michigan, LLC — Chesterfield

New York

  • Long Island Gastrointestinal Research Group, LLP — Great Neck

Utah

  • Advanced Research Institute — Ogden

Trial Details

FieldValue
Enrollment Target 621 participants
Start Date 2014-09
Est. Completion 2015-06
Phase Phase 3

Sponsor

Norgine

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02254486

The ClinicalTrials.gov registry entry for NCT02254486 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 621 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Norgine, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Colon Cancer appearing as the primary indexed condition, and to 2 interventions — of which NER1006 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02254486 reports 12 study locations spanning 7 distinct geographic areas — top geographies include North Carolina, Maryland, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02254486 about?

NCT02254486 is a clinical study titled "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". 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...

What is the current status of trial NCT02254486?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 621 participants. The study started on 2014-09. Estimated completion is 2015-06.

What conditions does trial NCT02254486 study?

This clinical trial studies the following conditions: Colon Cancer, Colorectal Carcinoma, Colon Cleansing. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02254486?

The interventions under investigation include: NER1006 (DRUG), Trisulfate solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02254486?

This trial is sponsored by Norgine, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02254486 being conducted?

This trial has 12 study locations across California, Maryland, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial