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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
In the afternoon/evening before colonoscopy: 1 litre solution plus 0.5 litre clear fluid. Day of colonoscopy: 1 litre solution plus at least up to 1 litre clear liquid.
Med. Klinik der
Wuppertal, Germany
Degree of gut cleansing
Degree of gut cleansing in each of five predefined gut segments (rectum, sigmoid colon, descending colon, transverse colon, ascending colon) rated on a 5-level verbal rating scale (VRS) ranging from 4 (very good) to 0 (very bad) by 1. the physician performing the endoscopic procedure and 2. by an independent reviewer on the basis of video tapes registered during colonoscopy.
Time frame: Day 0 during colonoscopy
Overall quality of colonic cleansing
Overall quality of colonic cleansing as rated on a 3-level VRS with ranks: A = very good or good colon cleansing in all five gut segments, B = at least one colon segment with moderate or bad cleansing result, C = very bad cleansing result in at least one colon segment.
Time frame: Day 0 during colonoscopy
Physicians overall judgement of colon preparation
Physicians overall judgement of colon preparation as assessed on a 5-level VRS ranging from very good to very bad.
Time frame: Day 0 during colonoscopy
Volume of fluid aspirated (ml)
Volume of fluid aspirated from intestinal lumen during colonoscopy.
Time frame: Day 0 during colonoscopy
Stool and urine weight (g)
Weight of stools and urine sampled from the beginning of gut preparation until the start of the endoscopic procedure.
Time frame: Day -1 and Day 0 prior to colonoscopy.
Clear effluent
Number of patients in whom a clear effluent (containing no residual faecal material) was obtained.
Time frame: Day -1 and Day 0 prior to colonoscopy.
Patient satisfaction - convenience
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Patients overall judgement of convenience of use of LDBP as assessed in the CRF on a on a 5-level VRS ranging from 4 (very good) to 0 (very bad).
Time frame: Day -1 and Day 0 prior to colonoscopy
Patient satisfaction - taste
Patients overall judgement of the taste of LDBP as assessed in the CRF on a on a VAS ranging from 0 (very bad) to 100 mm (very good).
Time frame: Day -1 and Day 0 prior to colonoscopy
Adverse events
• Occurrence of adverse events;
Time frame: Day -1 and Day 0 prior to colonoscopy
Global tolerance
Physicians global assessment of tolerability of LDBP as rated on a 4-level VRS ranging from (excellent) to (bad).
Time frame: Day -1 and Day 0 prior to colonoscopy
Hematology
A blood sample was obtained for hematology (hematocrit, hemoglobin, red and white blood cell count, platelet count) at baseline and after intake of the second dose of LDBP just before colonoscopy.
Time frame: Day -2 to Day 0 prior to colonoscopy
Serum chemistry
A blood sample was obtained for serum chemistry (electrolytes \[sodium, potassium, chloride, bicarbonate\], liver enzymes \[ASAT, ALAT\], total protein, blood urea nitrogen \[BUN\], creatinine, Quick time) at baseline and after intake of the second dose of LDBP just before colonoscopy.
Time frame: Day -2 to Day 0 prior to colonoscopy
Urine electrolytes
Amount of electrolytes (sodium, potassium, calcium) excreted in urine sampled from the beginning of gut preparation until the start of the endoscopic procedure.
Time frame: Day -1 to Day 0 prior to colonoscopy
Blood pressure (mmHg)
Blood pressure was measured at baseline, upon completion of LDBP intake, and after the end of colonoscopy.
Time frame: Day -2 to Day 0 after colonoscopy
Pulse rate (bpm)
Pulse rate in beats per minute (bpm) was measured at baseline, upon completion of LDBP intake, and after the end of colonoscopy.
Time frame: Day -2 to Day 0 after colonoscopy
Body weight (kg)
Actual body weight in kilograms (kg) was measured before and after the administration of LDBP.
Time frame: Day -1 prior to LDBP and Day 0 prior to colonoscopy.