Clinical trial NCT06597903: A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
Official title: A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use.

Detailed description: A pilot monocentric, open phase I study to investigate the efficacy and safety of a new oral gut cleansing solution NRL994 in patients submitted to colonoscopy.

The study was carried out as an open, uncontrolled investigation in a group of 36 in-patients scheduled for colonoscopy. Patients were enrolled one or two days prior to the endoscopic procedure. Gut cleansing started in the evening prior to the intervention when the first dose of LDBP was taken; bowel preparation was continued in the morning of the day of colonoscopy when the second dose was taken. A patient's participation in the study ended after completion of the endoscopic procedure.

A dose of NRL994 was diluted in 1000 mL of water and consisted of 100 g PEG 3350, 7.5 g sodium sulphate, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, 46 mmol sodium chloride, and 12.46 mmol potassium chloride. The product was flavoured with lemon flavour (2.015 g), anhydrous citric acid (1.565 g), and potassium acesulfame (0.35 g).

Each dose of one litre had to be swallowed within one hour, followed by 500 mL of additional clear fluid.

Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained prior to inclusion
* Male or female
* Inpatients 18 to 60 years old with indication for complete colonoscopy
* Willing and able to complete the entire procedure and to comply with study instructions
* Females of childbearing potential must employ an adequate method of contraception.

Exclusion Criteria:

* Ileus
* Intestinal obstruction or perforation.
* Toxic megacolon.
* History of any colonic surgery.
* Cardiac Insufficiency (NYHA grad III and IV).
* Ischemic cardio vascular disease.
* Renal insufficiency (creatinine above 1.4 mg/100 ml).
* Cirrhosis of liver (child B or C).
* Known hypersensitivity to polyethylene glycols and/or Vitamin C.
* Concurrent participation in an investigational drug study or participation within 30 days of study entry.
* Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
* Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
* Abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit
* Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmgH).

Primary outcomes:
measure: Degree of gut cleansing
timeFrame: Day 0 during colonoscopy
measure: Overall quality of colonic cleansing
timeFrame: Day 0 during colonoscopy
measure: Physicians overall judgement of colon preparation
timeFrame: Day 0 during colonoscopy
measure: Volume of fluid aspirated (ml)
timeFrame: Day 0 during colonoscopy
measure: Stool and urine weight (g)
timeFrame: Day -1 and Day 0 prior to colonoscopy.
measure: Clear effluent
timeFrame: Day -1 and Day 0 prior to colonoscopy.
measure: Patient satisfaction - convenience
timeFrame: Day -1 and Day 0 prior to colonoscopy
measure: Patient satisfaction - taste
timeFrame: Day -1 and Day 0 prior to colonoscopy
Secondary outcomes:
measure: Adverse events
timeFrame: Day -1 and Day 0 prior to colonoscopy
measure: Global tolerance
timeFrame: Day -1 and Day 0 prior to colonoscopy
measure: Hematology
timeFrame: Day -2 to Day 0 prior to colonoscopy
measure: Serum chemistry
timeFrame: Day -2 to Day 0 prior to colonoscopy
measure: Urine electrolytes
timeFrame: Day -1 to Day 0 prior to colonoscopy
measure: Blood pressure (mmHg)
timeFrame: Day -2 to Day 0 after colonoscopy
measure: Pulse rate (bpm)
timeFrame: Day -2 to Day 0 after colonoscopy
measure: Body weight (kg)
timeFrame: Day -1 prior to LDBP and Day 0 prior to colonoscopy.
Other outcomes:
measure: Easiness
timeFrame: Day -1 and Day 0 prior to colonoscopy
measure: Palatability
timeFrame: Day -1 and Day 0 prior to colonoscopy
Locations:
city: Wuppertal
country: Germany
facility: Med. Klinik der
Study officials:
affiliation: Dept. of Internal Medicine II, St. Antonius Hospital, Hardt 46, D-42 107 Wuppertal, Germany
name: K-J Goerg, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: