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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: NRL994

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Wuppertal, Germany, D-42107
    • Med. Klinik der

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NRL994 low dose bowel prep (LDBP); 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.

Drug: NRL994; 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.; Other Names: MOVIPREP; Low dose bowel prep (LDBP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; the physician performing the endoscopic procedure and; by an independent reviewer on the basis of video tapes registered during colonoscopy.	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.
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

Secondary Outcome Measures

Outcome Measure	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).	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.

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Norgine
• Investigators: Principal Investigator: K-J Goerg, PD Dr. med., Dept. of Internal Medicine II, St. Antonius Hospital, Hardt 46, D-42 107 Wuppertal, Germany

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): March 1, 2002
• Study Completion (Actual): March 1, 2002

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NRL994-01/2000

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No