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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRL994 low dose bowel prep (LDBP) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRL994 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 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. | 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. | Day 0 during colonoscopy |
| Volume of fluid aspirated (ml) | Volume of fluid aspirated from intestinal lumen during colonoscopy. | 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. | 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. | Day -1 and Day 0 prior to colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | • Occurrence of adverse events; | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Easiness | Patients overall judgement of convenience of use (easiness) of LDBP as assessed in the diary card on a on a 5-level VRS ranging from 4 (very good) to 0 (very bad). | Day -1 and Day 0 prior to colonoscopy |
| Palatability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K-J Goerg, PD Dr. med. | Dept. of Internal Medicine II, St. Antonius Hospital, Hardt 46, D-42 107 Wuppertal, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Med. Klinik der | Wuppertal | D-42107 | Germany |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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|
| Patient satisfaction - convenience | 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). | 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). | Day -1 and Day 0 prior to colonoscopy |
| 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. | 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. | 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. | 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. | 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. | 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. | Day -1 prior to LDBP and Day 0 prior to colonoscopy. |
Patient satisfaction with the palatability (taste and convenience) of the first and the second liter of LDBP cleansing solution ingested as assessed in the diary card on a 5-level VRS ranging from 4 (very good) to 0 (very bad)
Time Frame:
| Day -1 and Day 0 prior to colonoscopy |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |