Bowel PreparationPhase 3NCT03017235
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
A Phase 3 study testing Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution and Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder in people with Bowel Preparation, run by Ferring Pharmaceuticals at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution and Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 917 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 20 Feb 2017to 12 Oct 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Associated Gastroenterology Medical Group
Anaheim, California, 92801
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010
GW Research, Inc.
Chula Vista, California, 91910
Florida Clinical Research Group
Clearwater, Florida, 33759
Hillmont GI
Flourtown, Pennsylvania, 19031
Long Island Gastrointestinal Research Group LLC
Great Neck, New York, 11023
Clinical Research Associates
Huntsville, Alabama, 35801
Nature Coast Clinical Research
Inverness, Florida, 34452
Kinston Medical Specialists, PA
Kinston, North Carolina, 28501
Advanced Research Institute
Ogden, Utah, 84405
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Precision Research Institute
San Diego, California, 92114
Canada2 sites
Hotel Dieu Hospital
Kingston, K7L 5G2
Canadian Phase Onward, Inc.
Toronto, M3J 2C5
About this study
Official title: A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy
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.
- Conditions
- Bowel Preparation
- Being tested
- Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution, Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral SolutionDrug
Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric PowderDrug
Also called PREPOPIK®, PicoPrep®
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.
| Study group | Role | What they receive |
|---|---|---|
| NaP/MC Oral Solution | Experimental | Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Receives: Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution |
| PREPOPIK® | Active comparator | Not described Receives: Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
Secondary outcomes (22)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: During colonoscopy procedure (5-9 hours after completed treatment)
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.
Measured: From baseline (screening) up to day 28 after colonoscopy
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
Measured: From baseline (screening) up to day 28 after colonoscopy
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.
Measured: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
Clinically Significant Changes in Laboratory Values
Rated by the investigator based on out of range laboratory values
Measured: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start20 Feb 2017
- Primary completion15 Sep 2017
- Study completion12 Oct 2017
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 (4)Papers the sponsor has linked to this study.
- Other trials for Bowel PreparationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 917 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017235
- Sponsor's protocol ID
- 000253
- Status last verified
- Oct 2018
- First submitted
- 9 Jan 2017
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mankaney GN, Ando M, Dahdal DN, Burke CA. Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial. Ther Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 10.1177/17562848211024458. eCollection 2021.
PubMed 34262611Hookey L, Bertiger G, Johnson KL 2nd, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Apr 9;13:1756284820910050. doi: 10.1177/1756284820910050. eCollection 2020.
PubMed 32313553Hookey L, Bertiger G, Johnson KL, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Feb 7;13:1756284820902878. doi: 10.1177/1756284820902878. eCollection 2020.
PubMed 32095161Hookey L, Bertiger G, Lee Johnson K 2nd, Ayala J, Seifu Y, Brogadir SP. Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial. Ther Adv Gastroenterol. 2019 May 19;12:1756284819851510. doi: 10.1177/1756284819851510. eCollection 2019.
PubMed 31205487
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT03017235
- Acronym / sponsor ID
- 000253
- Conditions
- Bowel Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 917 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaP/MC Oral Solution | Experimental | Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral SolutionSodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution |
| PREPOPIK® | Active comparator | Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral SolutionSupplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration. | Drug | NaP/MC Oral Solution |
| Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric PowderAlso: PREPOPIK®, PicoPrep®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. | Drug | PREPOPIK® |
Primary outcome
Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
Time frame: 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.
22 secondary outcomes
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Percentage of Treatment-emergent Adverse Events(AEs)
Time frame: From baseline (screening) up to day 28 after colonoscopy
Clinically Significant Changes in Vital Signs
Time frame: From baseline (screening) up to day 28 after colonoscopy
Clinically Significant Changes in Electrocardiogram (ECG)
Time frame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
Clinically Significant Changes in 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34262611Mankaney GN, Ando M, Dahdal DN, Burke CA. Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial. Ther Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 10.1177/17562848211024458. eCollection 2021.
- Derived from this study: PubMed 32313553Hookey L, Bertiger G, Johnson KL 2nd, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Apr 9;13:1756284820910050. doi: 10.1177/1756284820910050. eCollection 2020.
- Derived from this study: PubMed 32095161Hookey L, Bertiger G, Johnson KL, Boules M, Ando M, Dahdal DN. Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study. Ther Adv Gastroenterol. 2020 Feb 7;13:1756284820902878. doi: 10.1177/1756284820902878. eCollection 2020.
- Derived from this study: PubMed 31205487Hookey L, Bertiger G, Lee Johnson K 2nd, Ayala J, Seifu Y, Brogadir SP. Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial. Ther Adv Gastroenterol. 2019 May 19;12:1756284819851510. doi: 10.1177/1756284819851510. eCollection 2019.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution and Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder in people with Bowel Preparation, run by Ferring Pharmaceuticals at 14 sites in 2 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 3 inclusion and 15 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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 14 Nov 2018). 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?
Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good" (time frame: During colonoscopy procedure (5-9 hours after completed treatment)). 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 NCT03017235, which also lists 4 linked publications.
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 14 Nov 2018; AzTrials last refreshed its copy on 30 Oct 2026.