A Randomised Controlled Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Ambulant colonoscopy
• Older than18
Locations
Other Locations
Denmark
Aalborg University hospital
RECRUITING
Aalborg
Contact Information
Primary
Hayder Alqaisi
haidermahmoud1991@gmail.com
+4591637005
Backup
Lars Andersen
L.maagaard@rn.dk
+4597661170
Time Frame
Start Date:2022-10-01
Estimated Completion Date:2025-12-01
Participants
Target number of participants:400
Treatments
Active_comparator: Picoprep
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.
Experimental: Plenvu
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.