Bowel Preparation
Conditions
Brief summary
The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.
Interventions
DRUGSodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution
Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
DRUGSodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy * Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation. * An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy
Exclusion criteria
* Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention * Acute intestinal or gastric ulceration * Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon * Undergoing colonoscopy for foreign body removal or decompression * Reduced level of consciousness or inability to swallow without aspiration * Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures * Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass) * Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites * Severely reduced renal function (\<30 mL/min/1.73 m2) * Pregnant or lactating women * Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1 * Rhabdomyolysis * Chronic nausea and vomiting * Hypermagnesemia * Undergoing treatment with Lithium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Classified as a Responder Defined by Excellent or Good | During colonoscopy procedure (5-9 hours after completed treatment) | The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is excellent or good on this 4-point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon | During colonoscopy procedure (5-9 hours after completed treatment) | The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. |
| Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon | During colonoscopy procedure (5-9 hours after completed treatment) | The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon | During colonoscopy procedure (5-9 hours after completed treatment) | The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
| Percentage of Treatment-emergent Adverse Events(AEs) | From baseline (screening) up to day 28 after colonoscopy | Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs. |
| Clinically Significant Changes in Vital Signs | From baseline (screening) up to day 28 after colonoscopy | Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position |
| Clinically Significant Changes in Electrocardiogram (ECG) | At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy | Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing. |
| Clinically Significant Changes in Laboratory Values | At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy | Rated by the investigator based on out of range laboratory values |
| Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | During colonoscopy procedure (5-9 hours after completed treatment) | Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NaP/MC Oral Solution Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution: Supplied as ready-to-drink without further reconstitution before administration | 448 |
| PREPOPIK® Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes. | 453 |
| Total | 901 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Cancer, emergency, allergy, active UTI | 4 | 2 |
| Overall Study | Lost to Follow-up | 2 | 7 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | NaP/MC Oral Solution | PREPOPIK® | Total |
|---|---|---|---|
| Age, Continuous | 57.2 Years STANDARD_DEVIATION 11.04 | 57.1 Years STANDARD_DEVIATION 10.85 | 57.2 Years STANDARD_DEVIATION 10.94 |
| Child-bearing potential Child bearing potential | 252 Participants | 250 Participants | 502 Participants |
| Child-bearing potential No | 203 Participants | 203 Participants | 406 Participants |
| Child-bearing potential Yes | 49 Participants | 47 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 68 Participants | 71 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 380 Participants | 381 Participants | 761 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 41 Participants | 90 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) White | 376 Participants | 394 Participants | 770 Participants |
| Sex: Female, Male Female | 252 Participants | 250 Participants | 502 Participants |
| Sex: Female, Male Male | 196 Participants | 203 Participants | 399 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 448 | 0 / 453 |
| other Total, other adverse events | 378 / 448 | 384 / 453 |
| serious Total, serious adverse events | 9 / 448 | 6 / 453 |
Outcome results
Primary
Percentage of Subjects Classified as a Responder Defined by Excellent or Good
The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is excellent or good on this 4-point scale.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The primary efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NaP/MC Oral Solution | Percentage of Subjects Classified as a Responder Defined by Excellent or Good | 87.7 Percentage of participants |
| PREPOPIK® | Percentage of Subjects Classified as a Responder Defined by Excellent or Good | 81.5 Percentage of participants |
Comparison: Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)p-value: 0.006795% CI: [1.8, 10.9]Weighted Percentage Difference
Secondary
Clinically Significant Changes in Electrocardiogram (ECG)
Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.
Time frame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
Population: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Atrial fibrillation | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Bradycardia | 3 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Bundle branch block left | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Extrasystoles | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Ventricular extrasystoles | 2 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Bundle branch block right | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Palpitations | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Sinus bradycardia | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Tachycardia | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Electrocardiogram (ECG) | Cardiac murmur | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Sinus bradycardia | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Ventricular extrasystoles | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Bundle branch block right | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Bradycardia | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Cardiac murmur | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Bundle branch block left | 2 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Palpitations | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Extrasystoles | 2 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Tachycardia | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Electrocardiogram (ECG) | Atrial fibrillation | 0 Participants |
Secondary
Clinically Significant Changes in Laboratory Values
Rated by the investigator based on out of range laboratory values
Time frame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
Population: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Hematology: Anaemia | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Hematology: Leukopenia | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Hematology: Lymphocytosis | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Hematology: Neutropenia | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Hematology: Normocytic anaemia | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Hemotology: Platelet count decreased | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical Chemistry: Hypermagnesaemia | 9 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry:Blood bicarbonate decreased | 6 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypokalemia | 4 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hyperglycaemia | 2 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypoglycaemia | 3 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hyperkalaemia | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypomagnasaemia | 2 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Blood creatinine increased | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Blood potassium decreased | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypochloraemia | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hyperbilirubinaemia | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Laboratory Values | Urinalysis | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Blood creatinine increased | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Hematology: Anaemia | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hyperglycaemia | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Hematology: Leukopenia | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Urinalysis | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Hematology: Lymphocytosis | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypoglycaemia | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Hematology: Neutropenia | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Blood potassium decreased | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Hematology: Normocytic anaemia | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hyperkalaemia | 2 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Hemotology: Platelet count decreased | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hyperbilirubinaemia | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical Chemistry: Hypermagnesaemia | 23 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypomagnasaemia | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry:Blood bicarbonate decreased | 3 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypochloraemia | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Laboratory Values | Clinical chemistry: Hypokalemia | 0 Participants |
Secondary
Clinically Significant Changes in Vital Signs
Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position
Time frame: From baseline (screening) up to day 28 after colonoscopy
Population: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Clinically Significant Changes in Vital Signs | Hypertension | 0 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Vital Signs | Orthostatic hypotension | 1 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Vital Signs | Blood pressure increased | 2 Participants |
| NaP/MC Oral Solution | Clinically Significant Changes in Vital Signs | Hypotension | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Vital Signs | Hypotension | 1 Participants |
| PREPOPIK® | Clinically Significant Changes in Vital Signs | Hypertension | 4 Participants |
| PREPOPIK® | Clinically Significant Changes in Vital Signs | Blood pressure increased | 0 Participants |
| PREPOPIK® | Clinically Significant Changes in Vital Signs | Orthostatic hypotension | 2 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Moderately bothered | 15 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | No response | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Severely bothered | 3 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Not applicable | 2 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Not bothered-Mildly bothered | 427 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Not bothered-Mildly bothered | 432 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Moderately bothered | 15 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | Severely bothered | 3 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) | No response | 2 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Moderately bothered | 63 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | No response | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Severely bothered | 11 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Not applicable | 2 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Not bothered-Mildly bothered | 371 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Not applicable | 0 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Not bothered-Mildly bothered | 426 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Moderately bothered | 22 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | Severely bothered | 2 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) | No response | 3 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Moderately bothered | 35 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | No response | 2 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Severely bothered | 7 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Not applicable | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Not bothered-Mildly bothered | 403 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Not bothered-Mildly bothered | 402 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Moderately bothered | 40 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | Severely bothered | 6 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) | No response | 4 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Moderately bothered | 53 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | No response | 2 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Severely bothered | 10 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Not applicable | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Not bothered-Mildly bothered | 382 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Not applicable | 0 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Not bothered-Mildly bothered | 387 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Moderately bothered | 57 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | Severely bothered | 6 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) | No response | 3 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Moderately bothered | 38 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | No response | 0 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Severely bothered | 13 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Not applicable | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Not bothered-Mildly bothered | 396 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Not bothered-Mildly bothered | 396 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Moderately bothered | 47 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | Severely bothered | 7 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) | No response | 2 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Moderately bothered | 86 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | No response | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Severely bothered | 25 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Not applicable | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Not bothered-Mildly bothered | 335 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Not applicable | 0 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Not bothered-Mildly bothered | 328 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Moderately bothered | 85 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | Severely bothered | 37 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) | No response | 3 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Moderately bothered | 23 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | No response | 2 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Severely bothered | 6 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Not applicable | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Not bothered-Mildly bothered | 416 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Not applicable | 0 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Not bothered-Mildly bothered | 435 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Moderately bothered | 11 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | Severely bothered | 2 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) | No response | 4 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | 4 to 8/week | 264 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | Response not provided | 0 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | ≥9/week | 120 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | Not applicable | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | ≤3/week | 63 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | ≤3/week | 47 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | 4 to 8/week | 299 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | ≥9/week | 105 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) | Response not provided | 1 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | <25% | 443 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | 25% - 50% | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | 50% - 75% | 0 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | ≥75% | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | Response not provided | 2 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | Response not provided | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | <25% | 448 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | ≥75% | 0 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | 25% - 50% | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) | 50% - 75% | 2 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Not willing at all | 11 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Somewhat willing | 75 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Mostly willing | 361 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Not willing at all | 6 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Mostly willing | 408 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) | Somewhat willing | 38 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | No | 104 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | No health issues | 84 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | No difficulties | 310 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | Response not provided | 0 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | Yes | 11 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | Response not provided | 3 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | Yes | 8 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | No | 93 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | No difficulties | 320 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) | No health issues | 109 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | Moviprep | 14 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | Other | 34 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | MiraLax | 20 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | Do not remember | 137 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | GoLytely | 56 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | Do not remember | 53 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | GoLytely | 52 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | Moviprep | 17 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | MiraLax | 20 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) | Other | 39 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | Worse than before | 5 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | About the same as before | 62 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | Better than before | 190 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | Response not provided | 4 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | Response not provided | 0 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | Worse than before | 5 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | Better than before | 209 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) | About the same as before | 67 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Somewhat difficult | 41 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Unacceptable | 2 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Very difficult | 4 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Not applicable | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Easy to acceptable | 400 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Easy to acceptable | 433 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Somewhat difficult | 17 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Very difficult | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) | Unacceptable | 1 Participants |
Secondary
Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | No | 261 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | Yes | 185 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | Response not provided | 1 Participants |
| NaP/MC Oral Solution | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | Not applicable | 1 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | Not applicable | 0 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | No | 281 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | Response not provided | 2 Participants |
| PREPOPIK® | Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) | Yes | 171 Participants |
Secondary
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NaP/MC Oral Solution | Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon | 94.6 Percentage of subjects |
| PREPOPIK® | Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon | 91.2 Percentage of subjects |
Comparison: Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)p-value: 0.039195% CI: [0.2, 6.7]Weighted Percentage Difference
Secondary
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NaP/MC Oral Solution | Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon | 94.2 Percentage of subjects |
| PREPOPIK® | Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon | 89.6 Percentage of subjects |
Comparison: Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)p-value: 0.009995% CI: [1.1, 8]Weighted Percentage Difference
Secondary
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Population: The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NaP/MC Oral Solution | Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon | 96.0 Percentage of subjects |
| PREPOPIK® | Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon | 94.0 Percentage of subjects |
Comparison: Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)p-value: 0.178195% CI: [-0.9, 4.7]Weighted Percentage Difference
Secondary
Percentage of Treatment-emergent Adverse Events(AEs)
Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.
Time frame: From baseline (screening) up to day 28 after colonoscopy
Population: The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NaP/MC Oral Solution | Percentage of Treatment-emergent Adverse Events(AEs) | 84.4 Percentage of adverse events |
| PREPOPIK® | Percentage of Treatment-emergent Adverse Events(AEs) | 84.8 Percentage of adverse events |