CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 515 enrolled
Drug / intervention
NER1006, Day Before-Only Dosing +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02273141
NCT02273141Phase 3Completed
CompareCT.gov

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 Sodium Picosulfate and Magnesium Salt (SP+MS) Solution Using Day Before-Only Dosing Regimen in Adults.

Norgine·interventional·Posted Oct 23, 2014·Updated May 15, 2018

In Brief

A Phase 3 clinical trial evaluating NER1006, Day Before-Only Dosing and SP+MS, Day Before-Only Dosing for Colorectal Cancer and 2 related conditions. Completed, enrolled 515 participants across 19 sites in 6 countries.

Detailed Summary

This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen. Approximately 484 patients will be randomised with the aim of achieving a minimum of 220 patients in each of the 2 groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer, Colorectal Carcinoma, Colon Cleansing
CountriesGermany, Italy, Netherlands, Poland, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 23, 2014
Enrollment StartNov 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.7 years ago

Interventions

NER1006, Day Before-Only Dosingdrug

The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose.

SP+MS, Day Before-Only Dosingdrug

The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.