Completed

OUTPharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects

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What is being tested

NER1006

+ NER1006

+ NER1006

Drug
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 45 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorNorgine
Last updated: April 18, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.

NCT01834742
Principal SponsorNorgine
Last updated: April 18, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

161 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

5 inclusion criteria required to participate
Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, 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. 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
Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms
Healthy subjects with an age of 18 to 45 years
The subject's written informed consent must be obtained prior to inclusion
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22 exclusion criteria prevent from participating
Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances
Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD])
Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation
Clinically relevant findings on physical examination based on Investigator's judgement
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

8 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Evening dose 1 plus fixed morning dose

Group II

Experimental
Evening dose 2 plus fixed morninf does

Group III

Experimental
Evening dose 3 plus fixed morning dose

Group IV

Active Comparator
Moviprep

Group 5

Experimental
Fixed evening dose plus morning dose 1

Group 6

Experimental
Fixed evening dose plus morning dose 2

Group 7

Experimental
Fixed evening dose plus morning dose 3

Group 8

Experimental
Fixed evening dose plus alternative morning dose

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Pierrel Research HP-RO-SRL

Timișoara, RomaniaOpen Pierrel Research HP-RO-SRL in Google Maps

Pierrel Research HP-RO-SRL

Timișoara, Romania
Completed2 Study Centers