Mode of Action of Moviprep

NCT01622972 | Completed Phase 4

• 2 other identifiers: 100502010-021879-85
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The University of Nottingham have been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the bowel. Building on those studies the investigators want to study, in healthy volunteers, the effects of purging on the colon. The investigators plan two studies using their novel MRI techniques in healthy volunteers to demonstrate how doses of a preparation designed to clean the bowel alters small and large bowel water content and transit. The investigators will also define the changes induced in colonic microbiota and how these are linked to changes in transit and the structure of colonic contents. This experimental model is comparable to an episode of acute diarrhea, therefore this study will also improve their understanding of the effects of diarrhea on bowel physiology. Following from the above study, the investigators would like to extend this study on patients who have functional constipation and previously have not responded to conventional laxatives.

Conditions

Functional Constipation; Irritable Bowel Syndrome Characterized by Constipation

Outcome Measures

Primary Outcomes (2)

• Effect of 1 or 2 litre of Moviprep on area under curve (AUC) small bowel water content 0-6 hours on healthy volunteers

  Healthy Volunteers

  up to 24 hours

• To assess area under curve of small bowel water content following 1litre of Moviprep on patients with constipation

  Patients with constipation

  up to 6 hours

Secondary Outcomes (12)

• Effect of 2 different dosing regimens of Moviprep on cleansing of the colon as assessed from colonic contents on the last scan at the end of purgation

  up to 24 hours

• Effect of 2 different dosing regimens of Moviprep on the time course of the intestinal water content

  6 weeks

• Effect of 2 different dosing regimens of Moviprep on the time course of the ascending colon total chyme volume

  6 weeks

• Effect of 2 different dosing regimens of Moviprep on the time course of the Colonic motility index 'cine' MRI movies

  6 weeks

• Effect of 2 different dosing regimens of Moviprep on the time course of the transit assessment from mean position of marker capsules

  6 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

Healthy volunteers in Group 1: To give sachet's A and B made up to 1 litre with tap water once on day 1 and once on day 2

Drug: Polyethyleneglycol

Group 2

EXPERIMENTAL

Healthy volunteers in group 2: To give 2x sachet's A and B made up to 2 litres with tap water on day 1.

Drug: Polyethyleneglycol

Group 3

EXPERIMENTAL

Patients with functional constipation and irritable bowel syndrome characterized by constipation: To give sachet's A and B made up to 1 litre with tap water once on day 1

Drug: Polyethyleneglycol

Interventions

Polyethyleneglycol DRUG

Group 1 sachet's A and B made up to 1 litre with tap water once on day 1 and once on day 2. Group 2 2x sachet's A and B made up to 2 litres with tap water on day 1. Group 3 sachet's A and B made up to 1 litre with tap water once on day 1.

Also known as: Macrogol 3350, Moviprep

Group 1; Group 2; Group 3

Eligibility Criteria

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

You may qualify if:

• Male or female healthy volunteers who are 18-65 years
• BMI 18-28 kg/m2
• Able to give voluntary written informed consent to participate in the study
• Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures
• Male or female who are 18-65 years
• BMI 18-30 kg/m2
• Able to give voluntary written informed consent to participate in the study
• Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures
• Patient diagnosed with constipation predominant irritable bowel syndrome who failed to respond to at least 1 laxative treatment in the past
• Patient diagnosed with functional constipation who failed to respond to 1-2 sachets of Movicol per day

You may not qualify if:

• Any history of serious acute or chronic illness especially gastrointestinal
• Diabetes Mellitus
• Pregnancy or breast feeding
• Smoking
• Unsuitable for MRI scanning (i.e. have metal implants or a pace maker)
• Regular use of medication interfering with gastrointestinal function including opiates or constipating drugs
• Subjects using the oral contraceptive pill will be excluded if not prepared to use an alternative barrier method of contraception for the duration of the menstrual cycle following dosing with Moviprep
• Substance abuse
• Have taken part in another clinical study within the previous 3 months
• Previous gastrointestinal surgery of any kind apart from appendicectomy
• Any history of serious acute or chronic illness especially gastrointestinal
• Diabetes Mellitus
• Pregnancy or breast feeding
• Unsuitable for MRI scanning (i.e. have metal implants or a pace maker)
• Regular use of medication interfering with gastrointestinal function including opiates or constipating drugs

Sponsors & Collaborators

• University of Nottingham: lead
• Norgine: collaborator

Study Sites (1)

Nottingham Digestive Diseases Centre, University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Interventions

polyethylene glycol 3350; MoviPrep

Study Officials

• Robin Spiller, MD FRCP

  University of Nottingham

  STUDY DIRECTOR

• Ching Lam, MBChB MRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Klara Garsed, MBChB MRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: September 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

GB (1)