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

NCT06597903 | Completed Phase 2 DMC

• 1 other identifier: NRL994-01/2000
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (8)

• 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.

  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 Outcomes (8)

• Adverse events

  Day -1 and Day 0 prior to colonoscopy

• Global tolerance

  Day -1 and Day 0 prior to colonoscopy

• Hematology

  Day -2 to Day 0 prior to colonoscopy

• Serum chemistry

  Day -2 to Day 0 prior to colonoscopy

• Urine electrolytes

  Day -1 to Day 0 prior to colonoscopy

Other Outcomes (2)

• Easiness

  Day -1 and Day 0 prior to colonoscopy

• Palatability

  Day -1 and Day 0 prior to colonoscopy

Study Arms (1)

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.

Drug: NRL994

Interventions

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.

Also known as: Low dose bowel prep (LDBP), MOVIPREP

NRL994 low dose bowel prep (LDBP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Med. Klinik der

Wuppertal, D-42107, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• K-J Goerg, PD Dr. med.

  Dept. of Internal Medicine II, St. Antonius Hospital, Hardt 46, D-42 107 Wuppertal, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: September 19, 2024
• Study Start: May 1, 2001
• Primary Completion: March 1, 2002
• Study Completion: March 1, 2002
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

DE (1)