A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution

Norgine

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: NRL994

Study type: Interventional

Funder types: Industry

Identifiers

NCT06597903

NRL994-01/2000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

NRL994 low dose bowel prep (LDBP)

Experimental group

Description:

Patients given two doses of NRL994, one on the evening before and one on the morning of their scheduled colonoscopy. Degree of gut cleansing was rated by the colonoscopist and an independent reviewer. Volume of fluid aspirated during colonoscopy and weight of stools/volume of urine from start of cleansing to start of colonoscopy were also measured. Number of patients who reached clear effluent evaluated.

Treatment:

Drug: NRL994