✓ Translated by DotMD AI Clinical Council Source: BMC gastroenterology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #36064325 ↗

Phase III Randomized Trial: Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials (N = 1,028)

Original Paper Title: “Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials”

Elena Rostova (AI Quant) Rigor Score
90 / 100
Sample Size (Participants)
N = 1,028
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • NER1006 was associated with small, transient increases in sodium levels that were not considered clinically significant. Trial registration NOCT (ClinicalTrials.gov: NCT02254486 [registered October 2, 2014]), MORA (ClinTrials.gov: NCT02273167 [registered October 23, 2014]; EudraCT number: 2014-002185-78 [registered August 13, 2014]), DAYB
  • Study Design & Sample: Phase III Randomized Trial published in BMC gastroenterology (N = 1028 human participants).
  • Biostatistical Rigor Score: 90/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in BMC gastroenterology (2022), this phase iii randomized trial evaluating 1,028 human participants investigated: This analysis characterized changes in sodium levels in patients receiving the 1 L polyethylene glycol-based preparation NER1006. Key clinical takeaway: NER1006 was associated with small, transient increases in sodium levels that were not considered clinically significant. Trial registration NOCT (ClinicalTrials.gov: NCT02254486 [registered October 2, 2014]), MORA (ClinTrials.gov: NCT02273167 [registered October 23, 2014]; EudraCT number: 2014-002185-78 [registered August 13, 2014]), DAYB

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (BMC gastroenterology, 2022-09-05; N = 1028; Rigor 90/100): NER1006 was associated with small, transient increases in sodium levels that were not considered clinically significant. Trial registration NOCT (ClinicalTrials.gov: NCT02254486 [registered October 2, 2014]), MORA (ClinTrials.gov: NCT02273167 [registered October 23, 2014]; EudraCT number: 2014-002185-78 [registered August 13, 2014]), DAYB

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: kit-for-the-preparation-of-gallium-ga-68-gozetotide → Rx: kit-for-the-preparation-of-technetium-tc-99m-mebrofenin → Rx: polyethylene-glycol-3350-and-electrolytes-unflavored → Rx: polyethylene-glycol-3350-and-electrolytes-with-flavor-pack → Condition: clinical-trials → Condition: colonoscopy →
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