Colorectal CancerPhase 3NCT02273141

Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus a Sodium Picosulfate and Magnesium Salt Solution Using Day Before-Only Dosing Regimen in Adults.

A Phase 3 study testing NER1006, Day Before-Only Dosing and SP+MS, Day Before-Only Dosing in people with Colorectal Cancer and Colorectal Carcinoma, run by Norgine at 19 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colorectal Cancer, Colorectal Carcinoma, Colon Cleansing
What is being tested?: NER1006, Day Before-Only Dosing and SP+MS, Day Before-Only Dosing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 515 participants
Where: 19 sitesin 6 countries
Study dates: Nov 2014to Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must provide 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 (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy):
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 the entire study and to comply with instructions.

Who cannot join

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.
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.

Show all 25Show fewer

Known phenylketonuria.
Known hypersensitivity to polyethylene glycols, ascorbic acid and sulfates (not including sulfa-based products), sodium picosulfate and magnesium salt compounds, or any other component of the study drug or comparator
Past history within the last 12 months or evidence of any on-going clinically relevant electrocardiogram 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 are ordered to live in an institution on court or authority order.
Patients with history of rhabdomyolysis

Trial locations and contacts

19 sites in 6 countries.

Country

City, postcode or hospital

19 sites in 6 countries

Netherlands4 sites

Onze Lieve Vrouwe Gashuis
Amsterdam
Albert Schweitzer Ziekenhuis
Dordrecht
Radboud UMC
Nijmegen
Orbis Medisch Centrum
Sittard

Other trials in Netherlands

Poland4 sites

Centrum Medyczne sw. Lukasza
Częstochowa
Instytut Medycyny Wsi im. Witolda Chodzki w
Lubliniec
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
Sopot
SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego
Szczecin

Other trials in Poland

Germany3 sites

Charité - Campus Virchow Klinikum
Berlin
University Hospital Schleswig-Holstein
Kiel, 24105
An der Germania Brauerei 6
Münster

Other trials in Germany

Italy3 sites

An der Germania Brauerei 6
Milan
Osp.San Raffaele U.O. Gastroenterologia
Milan
P.T.P.Nuovo Regina Margherita
Rome

Other trials in Italy

Spain3 sites

Hospital de Vinalopó, Unidad de Endoscopia Digestiva
Elche
Hospital Universitario de la Princesa
Madrid
Hospital Universitario La Paz, Unidad Enfermedad Intestinal
Madrid

Other trials in Spain

United Kingdom2 sites

Department of Surgery, Raigmore Hospital
Inverness
Derriford Hospital
Plymouth

Other trials in United Kingdom

About this study

Official title: 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.

Conditions: Colorectal Cancer, Colorectal Carcinoma, Colon Cleansing
Being tested: NER1006, Day Before-Only Dosing, SP+MS, Day Before-Only Dosing
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02273141
Study group	Role	What they receive
NER1006, Day Before-Only Dosing	Experimental	NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy). Receives: Drug: NER1006, Day Before-Only Dosing
SP+MS, Day Before-Only Dosing	Active comparator	SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy). Receives: Drug: SP+MS, Day Before-Only Dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

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 visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus SP+MS was evaluated using a non-inferiority study design.
Measured: One day (day before colonoscopy)
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 SP+MS was evaluated using a non-inferiority study design.
Measured: One day (day before colonoscopy)

Secondary outcomes (4)

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 SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.
Measured: One day (day before colonoscopy).
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 SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.
Measured: One day (day before colonoscopy)
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 SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.
Measured: One day (day before colonoscopy)
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 SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the overall colon.
Measured: One day (day before colonoscopy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Aug 2015

First posted23 Oct 2014 (estimated)
Study startNov 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 515 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02273141
Sponsor's protocol ID: NER1006-03/2014 (DAYB)
Status last verified: Apr 2018
First submitted: 16 Oct 2014
Last updated: 15 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Not yet recruitingPhase 2
Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma

All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT02273141
Acronym / sponsor ID: NER1006-03/2014 (DAYB)
Conditions: Colorectal Cancer, Colorectal Carcinoma, Colon Cleansing
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 515 participants (actual)
Lead sponsor: NorgineIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 23 Oct 2014 (estimated)
Results: Posted 18 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
NER1006, Day Before-Only Dosing	Experimental	Drug: NER1006, Day Before-Only DosingNER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
SP+MS, Day Before-Only Dosing	Active comparator	Drug: SP+MS, Day Before-Only DosingSP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients must provide 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 (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy):
Willing, able and competent to complete the entire study and to comply with instructions.

Key exclusion criteria (25 listed)

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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NER1006, Day Before-Only DosingThe 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.	Drug	NER1006, Day Before-Only Dosing
SP+MS, Day Before-Only DosingThe 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.	Drug	SP+MS, Day Before-Only Dosing

Primary outcome

Number of Patients With Successful Bowel Cleansing (Overall Colon)
Time frame: One day (day before colonoscopy)
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 visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus SP+MS was evaluated using a non-inferiority study design.
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Time frame: One day (day before colonoscopy)
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 SP+MS was evaluated using a non-inferiority study design.

4 secondary outcomes

Adenoma Detection Rate (Colon Ascendens)
Time frame: One day (day before colonoscopy).
Adenoma Detection Rate (Overall Colon)
Time frame: One day (day before colonoscopy)
Polyp Detection Rate (Colon Ascendens)
Time frame: One day (day before colonoscopy)
Polyp Detection Rate (Overall Colon)
Time frame: One day (day before colonoscopy)

Results and safety

Results posted to the registry on 18 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SP+MS, Day Before-Only Dosing	257	240
NER1006, Day Before-Only Dosing	258	233

Primary outcome: Number of Patients With Successful Bowel Cleansing (Overall Colon)

Time frame: One day (day before colonoscopy). Count of participants. Unit: Participants

Measure	SP+MS, Day Before-Only Dosing n = 251	NER1006, Day Before-Only Dosing n = 250
Successful	135	155
Failure	116	95

SP+MS, Day Before-Only Dosing vs NER1006, Day Before-Only Dosing: Difference in success rate: 8.22, p = 0.038, Fisher Exact

Population analysed: 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.

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

Time frame: One day (day before colonoscopy). Count of participants. Unit: Participants

Measure	SP+MS, Day Before-Only Dosing n = 251	NER1006, Day Before-Only Dosing n = 250
Excellent plus good	3	11
Adequate plus failure	248	239

SP+MS, Day Before-Only Dosing vs NER1006, Day Before-Only Dosing: Difference in excellent plus good rate: 3.20, p = 0.027, Fisher Exact

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Morning of Day 1 (first dose) to Day 9 (final clinic visit). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SP+MS, Day Before-Only Dosing	0 of 241 (0%)	9 of 241 (3.7%)	0 of 241
NER1006, Day Before-Only Dosing	1 of 235 (0.4%)	32 of 235 (13.6%)	0 of 235

Limitations and caveats (from the sponsor): Imputation of failure occurred in 4% of patients. This strict analytical approach reduced the cleansing success rates for both treatments.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36064325Cash 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.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Not yet recruitingPhase 2
Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stefan Schreiber principal investigator

University Hospital Schleswig-Holstein

19 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NER1006, Day Before-Only Dosing and SP+MS, Day Before-Only Dosing in people with Colorectal Cancer and Colorectal Carcinoma, run by Norgine at 19 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Netherlands, Poland, Germany, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Successful Bowel Cleansing (Overall Colon) (time frame: One day (day before colonoscopy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02273141, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.