Bowel Preparation and Prokinetics in Capsule Endoscopy

NCT00275184 | Unknown Phase 3

• 3 other identifiers: 05/CE/94REC 05/Q0405/94EudraCT No: 2005-004423-19
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether taking bowel preparation (citramag and senna) or a medicine to speed up transit through the stomach (metoclopramide), will improve the quality of the images seen, increase the transit through the small bowel, and increase the rate of completion of capsule endoscopy. The secondary objective is to determine whether patients could routinely tolerate this bowel preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy is improved.

Conditions

Small Bowel Disease; Gastrointestinal Hemorrhage; Refractory Anemia

Keywords

Bowel preparation; capsule endoscopy; randomised; Citramag; Senna; Metoclopramide; Patients referred for Capsule endoscopy; occult/overt gastrointestinal bleeding; other suspected small bowel pathology

Outcome Measures

Primary Outcomes (1)

• Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel

Secondary Outcomes (1)

• The tolerance of the bowel preparation to indicate future usage

Interventions

Senna DRUG

Citramag powder DRUG

Metoclopramide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 who have been referred for capsule endoscopy

You may not qualify if:

• Under 18
• Known or suspected gastrointestinal tract obstruction as this may impede passage of the capsule
• Known small bowel stricture or fistula as this may impede capsule passage
• Pregnancy, breast feeding or phaeochromocytoma as metoclopramide is contraindicated
• Recent gastrointestinal surgery in view of the risk of impeded capsule passage
• Permanent cardiac pacemaker or implantable defibrillator in-situ to avoid the risk of possible interference
• Congestive cardiac failure as citramag is contraindicated in such patients

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

St Mark's Hospital, North West London Hospitals NHS Trust

London, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Anemia, Refractory

Interventions

Sennosides; Metoclopramide

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Phenyl Ethers; Phenols

Study Officials

• Christopher Fraser, MB BCH, MD, FRCP

  St Mark's Hospital, North West London Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Fraser, MB BCH, MD, FRCP

CONTACT

chris.fraser@imperial.ac.uk

Neil Patterson, MB BCH, MD, MRCP

CONTACT

neil@rnpaterson.idps.co.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: January 1, 2006
• Last Updated: September 24, 2007

Record last verified: 2007-09

Locations

GB (1)