Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy

NCT01714466 | Completed Phase 2

• 1 other identifier: NER1006-01/2012 (OPT)
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (2)

• Stool weight output

  Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours

  36 hours post-dose

• Cleansing success rate

  The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)

  36 hours post-dose

Secondary Outcomes (7)

• Tolerability of medication (vomiting rate)

  36 hours post-dose

• EQ 5D patient questionnaire outcome (Part A only)

  36 hours post-dose

• Cleansing scores for each colon segment

  36 hours post-dose

• Time and volume of IMP to reach a clear effluent

  36 hours post-dose

• Ascorbate concentration

  36 hours post-dose

Study Arms (8)

Part A, arm 1

EXPERIMENTAL

Evening dose of TF048. Morning dose of TF043

Drug: NER1006

Part A, arm 2

EXPERIMENTAL

Evening dose of TF043. Morning dose of TF048

Drug: NER1006

Part A, arm 3

EXPERIMENTAL

Evening dose of TF047. Morning dose of TF043

Drug: NER1006

Part A, arm 4

ACTIVE COMPARATOR

MOVIPREP (Both evening and morning dose)

Drug: MOVIPREP

Part B, arm 1

EXPERIMENTAL

IMP selected based on the optimal dosing sequence and volume identified from Part A

Drug: NER1006

Part B, arm 2

EXPERIMENTAL

IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed

Drug: NER1006

Part B, arm 3

ACTIVE COMPARATOR

IMP as used in Part B, arm 1, except for a reduced amount of ascorbate

Drug: NER1006

Part B, arm 4

EXPERIMENTAL

MOVIPREP used in both evening and morning dose

Drug: MOVIPREP

Interventions

NER1006 DRUG

Part A, arm 1; Part A, arm 2; Part A, arm 3; Part B, arm 1; Part B, arm 2; Part B, arm 3

MOVIPREP DRUG

Part A, arm 4; Part B, arm 4

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age 40 to 70 years.
• Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject:
• is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or
• is aged 55 to 70.
• Part A: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
• Females of child bearing potential must be surgically sterile, post- menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in (unless post-menopausal).
• Willing, able and competent to complete the entire procedure and to comply with study instructions.
• Ferrous sulphate should be stopped at least one week prior to study medication.

You may not qualify if:

• Part A only: Subjects undergoing screening colonoscopy.
• Presence of current clinically significant functional gastrointestinal (GI) disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome \[IBS\]).
• Regular use of laxatives or colon motility altering drugs in the last month.
• Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
• Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
• Known glucose-6-phosphatase dehydrogenase deficiency.
• Known phenylketonuria.
• History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.
• Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
• History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.
• Evidence of dehydration.
• Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances.
• Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal.
• Clinically relevant findings on physical examination based on the Investigator's judgement.
• Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.

Sponsors & Collaborators

• Norgine: lead

Study Sites (2)

PAREXEL International Early Product Development Unit

Berlin, 14050, Germany

Location

Parexel International GmbH

Berlin, 14050, Germany

Location

Related Publications (1)

• Clayton LB, Tayo B, Halphen M, Kornberger R. Novel 1 L polyethylene glycol-based bowel preparation (NER1006): proof of concept assessment versus standard 2 L polyethylene glycol with ascorbate - a randomized, parallel group, phase 2, colonoscopist-blinded trial. BMC Gastroenterol. 2019 May 30;19(1):79. doi: 10.1186/s12876-019-0988-y.

  PMID: 31146679 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

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

Study Officials

• Rudiger Kornberger, MD

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

DE (2)