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CompletedNCT02254486NOCTUpdated May 15, 2018Results posted

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 Phase 3 interventional study of NER1006 and Trisulfate solution in Colon Cancer, Colorectal Carcinoma and Colon Cleansing, sponsored by Norgine. Completed at 12 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by Norgine · Phase 3, Interventional, and Screening

Phase
Phase 3
Study type
Interventional
Enrollment
621
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

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.

02

Conditions studied

  • Colon Cancer
  • Colorectal Carcinoma
  • Colon Cleansing
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 621 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Norgine is the lead sponsor of 52 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent
  • Male and female outpatients and inpatients aged ≥18 to ≤85 years undergoing a screening, surveillance, or diagnostic colonoscopy
  • Females of child bearing potential must have a negative pregnancy test at Screening and at Visit 2 and must be practising one of the following methods of birth control and agree to continue with the regimen throughout the study period: Oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; Intrauterine device in combination with a condom; Double barrier method (condom* and occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository)
  • Willing, able and competent to complete study and comply with instructions.

Exclusion criteria

Exclusion Criteria:

  • Patients with past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
  • Patients with ongoing severe acute Inflammatory Bowel Disease (IBD).
  • Patients who have had previous significant gastrointestinal surgeries, including colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning colostomy, Hartmann's procedure and de-functioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
  • Regular use of laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation.
  • Patients with active intestinal bleeding episodes or with a clinically significant low hemoglobin level \<9 g/dL for women and \<11 g/dL for men at screening.
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Known phenylketonuria.
  • Known hypersensitivity to polyethylene glycols, ascorbic acid and sulfates (not including sulfa-based products) or any other component of the investigational product or comparator.
  • Past history within the last 12 months or evidence of any on-going clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
  • History of uncontrolled hypertension with systolic blood pressure >170 mmHg and diastolic blood pressure >100 mmHg.
  • Patients with cardiac insufficiency NYHA grades III or IV.
  • Patients with moderate to severe renal insufficiency (i.e. with GFR, \<60 mL/min/1.73m2).
  • Patient with serum albumin \< 3.4 g/dL.
  • Patients with liver disease of grades B and C according to the Child Pugh classification.
  • Patients suffering from dehydration at screening as evaluated by the Investigator from physical examination and laboratory investigations.
  • Patients with clinically significant electrolyte abnormalities, whether pre-existing or noted at screening, such as hypernatremia, hyponatremia, hyperphosphatemia, hypermagnesemia, hypokalemia, hypocalcaemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
  • Patients with any other clinically significant hematological parameters including coagulation profile at screening.
  • Patients with impaired consciousness that might predispose them to pulmonary aspiration.
  • Patients undergoing colonoscopy for foreign body removal and/or decompression.
  • Patients who are pregnant or lactating, or intending to become pregnant during the study.
  • Clinically relevant findings on physical examination based on the Investigator's judgment.
  • History of drug or alcohol abuse within the 12 months prior to dosing.
  • Concurrent participation in an investigational drug or device study or participation within three months of study entry.
  • Patients who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures, e.g. cognitively impaired, debilitated or fragile patients.
  • Patients who are ordered to live in an institution on court or authority order.
05

Study design

Phase
Phase 3
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
621 participants (actual)

Study arms

  • Experimental
    NER1006, 2-Day Split-Dosing

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

    Drug: NER1006

  • Active comparator
    Trisulfate Solution, 2-Day Split-Dosing

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

    Drug: Trisulfate solution

Interventions

  • DrugNER1006

    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.

  • DrugTrisulfate solution

    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.

06

What researchers measure

Primary outcomes

  1. Number of Patients With Successful Bowel Cleansing (Overall Colon)

    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.

    Time frame: Two days (from day of first dosing to day of colonoscopy)

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

    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.

    Time frame: Two days (from day of first dosing to day of colonoscopy)

Secondary outcomes

  1. Adenoma Detection Rate (Colon Ascendens)

    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.

    Time frame: Two days (from day of first dosing to day of colonoscopy)

  2. Adenoma Detection Rate (Overall Colon)

    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.

    Time frame: Two days (from day of first dosing to day of colonoscopy)

  3. Polyp Detection Rate (Colon Ascendens)

    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.

    Time frame: Two days (from day of first dosing to day of colonoscopy)

  4. Polyp Detection Rate (Overall Colon)

    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.

    Time frame: Two days (from day of first dosing to day of colonoscopy)

07

Results

Posted May 23, 2017
Limitations and caveats
Imputation of failure occurred in 7% of patients. This strict analytical approach reduced the cleansing success rates for both treatments.

Participant flow

The trial recruited out/in-patients at 12 medical centres in the USA, from September 2014 to May 2015.

Participant flow — Overall Study
MilestoneTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
Started311310
Completed261255
Not completed5055
Withdrew: Adverse event11
Withdrew: Lack of efficacy10
Withdrew: Lost to follow-up24
Withdrew: Protocol violation12
Withdrew: Withdrawal by subject1715
Withdrew: Gfr<60ml/min1621
Withdrew: Various1212

Outcome measures

PrimaryNumber of Patients With Successful Bowel Cleansing (Overall Colon)

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.

Time frame:
Two days (from day of first dosing to day of colonoscopy)
Reported as:
Count of participants · Participants
Number of Patients With Successful Bowel Cleansing (Overall Colon)
ParticipantsTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
Successful238235
Failure4241
Statistical analysis
  • Trisulfate Solution 2-Day Split-Dosing vs NER1006 2-Day Split-Dosing · Fisher Exact · p = 0.528 (P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.) · Difference in success rate: 0.14
PrimaryNumber of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)

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.

Time frame:
Two days (from day of first dosing to day of colonoscopy)
Reported as:
Count of participants · Participants
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
ParticipantsTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
Excellent plus good8299
Adequate plus failure198177
Statistical analysis
  • Trisulfate Solution 2-Day Split-Dosing vs NER1006 2-Day Split-Dosing · Fisher Exact · p = 0.059 (P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value \<0.025; the threshold for statistical significance.) · Difference in excellent plus good rate: 6.58
SecondaryAdenoma Detection Rate (Colon Ascendens)

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.

Time frame:
Two days (from day of first dosing to day of colonoscopy)
Reported as:
Count of participants · Participants
Adenoma Detection Rate (Colon Ascendens)
ParticipantsTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
Patients with no adenomas detected232237
Patients with at least one adenoma detected4839
Statistical analysis
  • Trisulfate Solution 2-Day Split-Dosing vs NER1006 2-Day Split-Dosing · Fisher Exact · p = 0.863 (To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.) · Difference in adr: -3.01 · 95% CI -11.36 to 5.28
SecondaryAdenoma Detection Rate (Overall Colon)

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.

Time frame:
Two days (from day of first dosing to day of colonoscopy)
Reported as:
Count of participants · Participants
Adenoma Detection Rate (Overall Colon)
ParticipantsTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
Patients with no adenomas detected182183
Patients with at least one adenoma detected9893
Statistical analysis
  • Trisulfate Solution 2-Day Split-Dosing vs NER1006 2-Day Split-Dosing · Fisher Exact · p = 0.660 (To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.)
SecondaryPolyp Detection Rate (Colon Ascendens)

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.

Time frame:
Two days (from day of first dosing to day of colonoscopy)
Reported as:
Count of participants · Participants
Polyp Detection Rate (Colon Ascendens)
ParticipantsTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
Patients with no polyps detected213225
Patients with at least one polyp detected6751
Statistical analysis
  • Trisulfate Solution 2-Day Split-Dosing vs NER1006 2-Day Split-Dosing · Fisher Exact · p = 0.953 (To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.)
SecondaryPolyp Detection Rate (Overall Colon)

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.

Time frame:
Two days (from day of first dosing to day of colonoscopy)
Reported as:
Count of participants · Participants
Polyp Detection Rate (Overall Colon)
ParticipantsTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
Patients with no polyps detected144150
Patients with at least one polyp detected136126
Statistical analysis
  • Trisulfate Solution 2-Day Split-Dosing vs NER1006 2-Day Split-Dosing · Fisher Exact · p = 0.781

Adverse events

Collected over Afternoon of Day 1 (first dose) to Day 9 (final clinic visit). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Trisulfate Solution 2-Day Split-Dosing0/265 (0%)1/265 (0.4%)32/265 (12.1%)
NER1006 2-Day Split-Dosing0/262 (0%)1/262 (0.4%)73/262 (27.9%)
Most frequent serious events
Most frequent serious events
EventTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
IleusGastrointestinal disorders0/2651/262
Gastrintestinal haemorrhageGastrointestinal disorders1/2650/262
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTrisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-Dosing
NauseaGastrointestinal disorders5/26518/262
VomitingGastrointestinal disorders7/26516/262
DehydrationMetabolism and nutrition disorders1/2658/262
Abdominal TendernessGastrointestinal disorders1/2656/262
HeadacheNervous system disorders2/2655/262
Glomerular filtration rate decreasedInvestigations5/2654/262
FatigueGeneral disorders3/2654/262
Abdominal DistensionGastrointestinal disorders2/2653/262
GastritisGastrointestinal disorders3/2653/262
Hiatus herniaGastrointestinal disorders1/2653/262

Baseline characteristics

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).

Age, Categorical
Age, Categorical(Participants)Trisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-DosingTotal
<=18 years101
Between 18 and 65 years238243481
>=65 years7267139
Age, Continuous
Age, Continuous(Years)Trisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-DosingTotal
Mean57.3 ± 10.5657.7 ± 10.3657.5 ± 10.44
Sex: Female, Male
Sex: Female, Male(Participants)Trisulfate Solution 2-Day Split-DosingNER1006 2-Day Split-DosingTotal
Female142152294
Male169158327
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Study locations

12 sites
  • Anaheim Clinical Trials
    Anaheim, California 92801, United States
  • Investigative Clinical Research
    Annapolis, Maryland 21401, United States
  • MGG Group Co., Inc., Chevy Chase Clinical
    Chevy Chase, Maryland 20815, United States
  • Clinical Research Institute of Michigan, LLC
    Chesterfield, Michigan 48047, United States
  • Long Island Gastrointestinal Research Group, LLP
    Great Neck, New York 11023, United States
  • Cumberland Research Associates, LLC
    Fayetteville, North Carolina 28304, United States
  • Peters Medical Research
    High Point, North Carolina 27262, United States
  • Wake Research Associates, LLC
    Raleigh, North Carolina 27612, United States
  • Trial Management Associates, LLC
    Wilmington, North Carolina 24803, United States
  • Consultants for Clinical Research
    Cincinnati, Ohio 45219, United States
  • Investigative Clinical Research, LLC
    Mentor, Ohio 44060, United States
  • Advanced Research Institute
    Ogden, Utah 84405, United States
09

References and documents

Publications

  • DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10. PubMed 28803744 ↗
  • Cash BD, Allen C, Poppers DM. Transient alterations in plasma sodium concentrations with NER1006 bowel preparation: an analysis of three phase III, randomized clinical trials. BMC Gastroenterol. 2022 Sep 5;22(1):412. doi: 10.1186/s12876-022-02484-7. PubMed 36064325 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02254486
Lead sponsor
Norgine
Responsible party
Sponsor
First posted
Oct 2, 2014
Start date
Sep 2014
Primary completion
Jun 2015
Completion
Jun 2015
Results posted
May 23, 2017
Last update
May 15, 2018

Study contacts

Michael Demicco
principal investigator · Anaheim Clinical Trials, CA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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