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Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined

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ClinicalTrials.gov Identifier: NCT03965182
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

Brief Summary:

Sodium picosulfate/magnesium citrate (SPMC) is generally better tolerated than PEG, its cleansing effect remains uncertain. While most studies showed SPMC was non-inferior to PEG, some studies reported that SPMC was less effective than PEG. To improve the bowel cleansing effect of SPMC, splitting the dose by using one sachet the evening before colonoscopy and the other sachet 4 to 5 hours before colonoscopy in the morning, has been proposed.Adding bisacodyl to the regimen also has been shown to be helpful. Some side effects, such as hyponatremia, dehydration and sleep disturbance, were reported to be more commonly associated with SPMC than with PEG.

To enhance the efficacy and reduce the side effects, two studies have evaluated the combination of SPMC and PEG, with conflicting results.The effect of combining PEG and SPMC should be best appreciated with head-to-head comparison with PEG and SPMC alone at the same time.

Therefore we designed this head-to-head comparison study for 2 L PEG, 1L PEG plus one sachet of SPMC and 2 sachet of SPMC, all with split-dose and the addition of 10 ml bisacodyl. Our hypothesis is the bowel cleansing effect of the combination regimen was not inferior to PEG alone. The tolerability, acceptability and side effects of the 3 regimen will also be evaluated.

Patients will be randomly assigned to either PEG, PEG plus SPMC or SPMC group, in a 1:1:1 ratio using a computer-generated sequence. The treatment allocation will be concealed and revealed by non-research medical personnel at the screening visit.


Condition or disease Intervention/treatment Phase
Bowel Preparation Drug: PEG Drug: PEG plus SPMC Drug: SPMC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Head-to-head Comparison Study of Polyethylene Glycol, Polyethylene Glycol Plus Sodium Picosulfate, and Sodium Picosulfate
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PEG group
Patients in the PEG group were instructed to take the first sachet of PEG at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.
Drug: PEG
2 sachets of PEG will be used as the bowel prep regimen.

Active Comparator: PEG plus SPMC group
Patients in the PEG plus SPMC group will be instructed to take the SPMC sachet at 19:00 hours the day before colonoscopy and the PEG sachet at 6:00 hours on the morning of the day of colonoscopy.
Drug: PEG plus SPMC
one sachet of PEG and one sachet will be administered as the bowel prep regimen

Active Comparator: SPMC group
Patients in the SPMC group were instructed to take the first sachet of SPMC at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.
Drug: SPMC
2 sachets will be administered as the bowel prep regimen.




Primary Outcome Measures :
  1. Aronchick scale [ Time Frame: through study completion, average 30 minutes ]
    a validated assessment that describes the visual appearance of the colon on a four-point scale.

  2. Boston Bowel Preparation Scale [ Time Frame: through study completion, average 30 minutes ]
    BBPS is based on the summation of the preparation scores from three segments of the colon (cecum and ascending, transverse colon and left colon). A segment score of 0 describes an"unprepared colon segment with mucosa not well seen due to solid stool that cannot be cleared"; segment score 1: "portion of mucosa of the colon segment seen, but other areas of the colon are not well seen due to staining, residual stool and⁄or opaque liquid"; segment score 2: "minor amount of residual staining, small fragments of stool and⁄or opaque liquid, but mucosa of colon segment seen well"; segment score 3: "entire mucosa of the colon segment seen well with no residual staining, small fragments of stool and⁄or opaque liquid".


Secondary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: when pathology of polyps become available, average in one week. ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible patients will include those anticipated to undergo colonoscopy, aged 20 to 80 at the time of enrollment.

Exclusion Criteria:

  • previous colon resection, gastrointestinal obstruction, ileus, intestinal perforation, toxic megacolon, active stage of inflammatory bowel disease, congestive heart failure (New York Heart Association Class III or IV),acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure>100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute) or any allergy to, PEG, or sodium picosulfate solution, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965182


Contacts
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Contact: Yu-Hsi Hsieh, MD 886-5-2648000 ext 5204 hsiehyuhsi1112@gmail.com

Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
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Principal Investigator: Yu-Hsi Hsieh, MD Buddhist Dalin Tzu Chi Hospital
Publications:

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Responsible Party: Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03965182    
Other Study ID Numbers: A10801001
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalin Tzu Chi General Hospital:
colon preparation, ,
polyethylene glycol
sodium picosulfate/magnesium citrate