A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy

NCT05436054 | Recruiting Phase 4 DMC

• 1 other identifier: 122021
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease. 400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents. The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.

Conditions

Colon Disease

Keywords

colonoscopy; bowel cleansing

Outcome Measures

Primary Outcomes (1)

• Efficacy of cleansing agent

  The primary endpoint is the efficacy of cleansing preparations measured by the quality of cleansing. This is done using the validated Harefield Cleansing Scale. The cleansing quality is measured after dividing the colon into 5 segments (Rectum, sigmoid colon, Descending colon, Transverse colon, and Ascending colon/Cecum) and each segment is scored from 0 (irremovable heavy hard stool), 1 (Semi-solid, only partially removable stools), 2 (Brown liquid/removable semi-solid stools) 3 (Clear liquid), and 4 (empty and clean), then a total grade is given. Grade A (all segments scored 3 or 4) and B (one or more segments scored 2) are considered as successful cleansing. Grade C (one or more segments scored 1) and D (one or more segments scored 0) is considered unsuccessful cleansing.

  18 hours

Secondary Outcomes (1)

• Tolerability to the cleansing agent

  18 hours

Study Arms (2)

Picoprep

ACTIVE COMPARATOR

Picoprep®: Active substances: An envelope Picoprep® contains 10 mg sodium picosulfate, 3,5 g magnesium oxide, and 12 g citric acid. Mechanism of action: Sodium picosulfate is a peristaltic agent that increases the peristalsis of the intestine. Magnesium oxide and citric acid are osmotic agents to increase water content in the bowel. Dosage and administration: consist of 2 envelopes, the first envelope, after dissolving in 150 ml water, should be taken 10-18 hours before the colonoscopy, then at least 250mlX5 clear fluid (not only water) over the next hours before the second dose is taken. The second envelope should be taken 4-6 hours before colonoscopy followed by 250mlX3 clear fluid (not only water) over the next hours before colonoscopy. The total fluid intake is approximately 2.3 L.

Drug: Picoprep

Plenvu

EXPERIMENTAL

Plenvu®: Active substances: Dose nr. 1 1 envelope contains 1 g potassium chloride, 100 g macrogol 3350, 2 g sodium chloride, and 9 g sodium sulfate. Dose nr. 2 1 envelope A contains 1,2 g potassium chloride, 40 g macrogol 3350, and 3,2 g sodium chloride. 1 envelope B contains 7,54 g ascorbic acid (Vit. C) and 48,11 g sodium ascorbate. Mechanism of action: Macrogol 3350 is an osmotic laxative. The added electrolytes are to prevent electrolyte shifting and systemic disturbances. Dosage and administration: two separate nonidentical 500 ml doses are given. 2-day regime: dose nr.1 envelope is dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock evening before colonoscopy day. Dose nr.2 envelope A and B are dissolved in 500 ml post water and drunk over 30 minutes. Should be taken at 6 o'clock on the morning of colonoscopy day. After each dose of the dissolved Plenvu®, the patient should drink at least 500ml clear fluid.

Drug: Plenvu

Interventions

Picoprep DRUG

200 patients will be randomised to this arm

Picoprep

Plenvu DRUG

200 patients will be randomised to this arm

Plenvu

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulant colonoscopy
• Older than18

You may not qualify if:

• Younger than 18
• Known with severe heart failure
• Known with severe renal failure (eGFR\<30)
• Known for colonic stenosis
• Pregnant or breastfeeding
• Acute colonoscopy
• Cancer screening program colonoscopy
• Mentally retarded
• Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.
• Patients with Phenylketonuria
• Patients with Glucose-6-phosphate-dehydrogenase deficiency
• Patients with colon or rectum resection

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Regionshospital Nordjylland: collaborator
• Norgine: collaborator

Study Sites (1)

Aalborg University hospital

Aalborg, North Jutland, 9000, Denmark

RECRUITING

Related Publications (9)

• Cash BD, Moncrief MBC, Epstein MS, Poppers DM. Patient experience with NER1006 as a bowel preparation for colonoscopy: a prospective, multicenter US survey. BMC Gastroenterol. 2021 Feb 15;21(1):70. doi: 10.1186/s12876-021-01605-y.

  PMID: 33588763 BACKGROUND

• Byrne MF. The curse of poor bowel preparation for colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1587-90. doi: 10.1111/j.1572-0241.2002.05855.x. No abstract available.

  PMID: 12135005 BACKGROUND

• Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.

  PMID: 11419832 BACKGROUND

• Weir MA, Fleet JL, Vinden C, Shariff SZ, Liu K, Song H, Jain AK, Gandhi S, Clark WF, Garg AX. Hyponatremia and sodium picosulfate bowel preparations in older adults. Am J Gastroenterol. 2014 May;109(5):686-94. doi: 10.1038/ajg.2014.20. Epub 2014 Mar 4.

  PMID: 24589671 BACKGROUND

• Jin Z, Lu Y, Zhou Y, Gong B. Systematic review and meta-analysis: sodium picosulfate/magnesium citrate vs. polyethylene glycol for colonoscopy preparation. Eur J Clin Pharmacol. 2016 May;72(5):523-32. doi: 10.1007/s00228-016-2013-5. Epub 2016 Jan 28.

  PMID: 26818765 BACKGROUND

• Maida M, Sinagra E, Morreale GC, Sferrazza S, Scalisi G, Schillaci D, Ventimiglia M, Macaluso FS, Vettori G, Conoscenti G, Di Bartolo C, Garufi S, Catarella D, Manganaro M, Virgilio CM, Camilleri S. Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study. World J Gastroenterol. 2020 Apr 28;26(16):1950-1961. doi: 10.3748/wjg.v26.i16.1950.

  PMID: 32390705 BACKGROUND

• Halphen M, Heresbach D, Gruss HJ, Belsey J. Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. 2013 Jul;78(1):121-31. doi: 10.1016/j.gie.2013.02.009. Epub 2013 Mar 24.

  PMID: 23531426 BACKGROUND

• Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci. 2013 Apr;58(4):926-35. doi: 10.1007/s10620-012-2449-0. Epub 2012 Oct 25.

  PMID: 23095990 BACKGROUND

• Lyseng-Williamson KA. Macrogol (polyethylene glycol) 4000 without electrolytes in the symptomatic treatment of chronic constipation: a profile of its use. Drugs Ther Perspect. 2018;34(7):300-310. doi: 10.1007/s40267-018-0532-0. Epub 2018 Jun 15.

  PMID: 30546252 BACKGROUND

MeSH Terms

Conditions

Colonic Diseases

Interventions

picosulfate sodium; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Lars Andersen, Consultant

  Region of North Jutland

  STUDY DIRECTOR

Central Study Contacts

Hayder Alqaisi

CONTACT

+4591637005; haidermahmoud1991@gmail.com

Lars Andersen

CONTACT

+4597661170; L.maagaard@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blinded trial. The colonoscopist who performs the procedure and evaluates the quality of cleansing is blinded to which preparation was used. This is achieved during randomisation of the patient where they receive a paper form prescription, thus the colonoscopist cannot check that in the electronic system. Blinding is not done to the patients as the bias is considered small. Cleansing agents are not normally used in the general population and the effect of previous experience to evaluate the tolerability in the present time is not considered to be large. Subjects will be well informed in the participation information and in the meeting not to reveal the type of cleansing they received to the colonoscopist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Model Details: This is a single-center, single-blinded, randomised equivalence trial to compare the efficacy and tolerability of Picoprep® and Plenvu® as cleansing agents before colonoscopy. The trial is to be performed on patients referred to Frederikshan endoscopy center for a colonoscopy, most of these patients are referred to exclude/diagnose colon cancer. Colonoscopies are performed in Frederikshavn local hospital/North Jutland/Denmark by different colonoscopists.

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 28, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

DK (1)