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NER1006:2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)

Trisulfate Solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)

The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.

NER1006

Trisulfate solution

Michael Demicco

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.

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

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

The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.

The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate Solution was evaluated using a non-inferiority study design.

Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.

Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. ADR defined as the number of patients with at least one adenoma in the overall colon.

Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.

Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. PDR defined as the number of patients with at least one polyp in the overall colon.

Norgine

Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=527). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and neither of the serious TEAEs was related to treatment.

Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)

Trisulfate Solution 2-Day Split-Dosing

NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)

NER1006 2-Day Split-Dosing

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

The number of participants for analysis, 245 per arm, was based on assumed overall cleansing success rates of 90% for both Trisulfate Solution (TS) and NER1006, a non-inferiority (NI) margin of 10%, and at least 90% power to demonstrate NI. The overall number of participants analyzed was based on the modified full analysis set (mFAS).

Imputation of failure occurred in 7% of patients. This strict analytical approach reduced the cleansing success rates for both treatments.

Lucy Clayton

The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.

Successful

Failure

The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.

Number of Patients With Successful Bowel Cleansing (Overall Colon)

Excellent plus good

Adequate plus failure

Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)

If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.

Patients with no adenomas detected

Patients with at least one adenoma detected

The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug

Adenoma Detection Rate (Colon Ascendens)

Adenoma Detection Rate (Overall Colon)

If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.

Patients with no polyps detected

Patients with at least one polyp detected

Polyp Detection Rate (Colon Ascendens)

If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.

Polyp Detection Rate (Overall Colon)

Overall Study

Colonic Neoplasms

Evening dose of TF048. Morning dose of TF043

Evening dose of TF043. Morning dose of TF048

Evening dose of TF047. Morning dose of TF043

IMP selected based on the optimal dosing sequence and volume identified from Part A

IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed

IMP as used in Part B, arm 1, except for a reduced amount of ascorbate

MOVIPREP used in both evening and morning dose

MOVIPREP

Rudiger Kornberger, MD

A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)

Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy

Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours

The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)

The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B

Patients to use the EQ 5D patient questionnaire to assess their study medication for part A

The segmental cleansing scores for each of the five colon segments

The time and volume taken for the IMP to reach a clear effluent

Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)

Concentration of electrolytes in blood, urine and faeces

Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities

Micronutrients

Gastrointestinal Agents

Vitamins

Ascorbic Acid

Laxatives

Polyethylene glycol 3350

Sodium sulfate

Cathartics

Vitamin C

Fixed evening dose plus alternative morning dose

Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.

Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.

Moviprep

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.

Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.

Rodica Cinca, MD

This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.

Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects

Stool weight output generated from the start of intake for the following 24 hours.

Concentration of PEG3350 in blood, urine and faeces.

Concentration of ascorbic acid in blood, urine and faeces.

Concentration of electrolytes in blood, urine and faeces.

Spontaneouly reported adverse events will be recorded throughout the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	Colon Cancer Colorectal Carc... Colon Cleansing	NER1006 Trisulfate solu...	18 Years - 85 Years	Norgine
Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy	NCT01714466	Colon Cancer	NER1006 MOVIPREP	40 Years - 70 Years	Norgine
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects	NCT01834742	Colorectal Canc...	NER1006 NER1006 NER1006 Moviprep NER1006 NER1006 NER1006 NER1006	18 Years - 45 Years	Norgine
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects	NCT01834742	Colorectal Canc...	NER1006 NER1006 NER1006 Moviprep NER1006 NER1006 NER1006 NER1006	18 Years - 45 Years	Norgine
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	Colon Cancer Colorectal Carc... Colon Cleansing	NER1006 Trisulfate solu...	18 Years - 85 Years	Norgine
Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy	NCT01714466	Colon Cancer	NER1006 MOVIPREP	40 Years - 70 Years	Norgine

Spots Global Cancer Trial Database for ner1006

Every month we try and update this database with for ner1006 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ner1006

Every month we try and update this database with for ner1006 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ner1006 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.