Small Bowel DiseasePhase 3NCT00275184
Bowel Preparation and Prokinetics in Capsule Endoscopy
A Phase 3 study testing Senna, Citramag powder and Metoclopramide in people with Small Bowel Disease and Gastrointestinal Hemorrhage, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Disease, Gastrointestinal Hemorrhage, Refractory Anemia
- What is being tested?
- Senna, Citramag powder and Metoclopramide
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 who have been referred for capsule endoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Christopher Fraser, MB BCH, MD, FRCP contact
Neil Patterson, MB BCH, MD, MRCP contact
United Kingdom1 site, 1 recruiting
- Recruiting
St Mark's Hospital, North West London Hospitals NHS Trust
London, HA1 3UJ
Alan Warnes, PhD, alan.warnes@nwlh.nhs.ul
Iva Hauptmannova, BSc, MA, iva.hauptmannova@nwlh.nhs.uk
About this study
Official title: A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
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.
Read the detailed description
Capsule endoscopy is a diagnostic tool for the detection of small bowel disease allowing noninvasive endoscopic examination of the entire small bowel without the need for sedation. Its limited battery life of 8+/-1 hours means it is paramount that the Capsule reaches the caecum, visualizing the whole of the small intestine, and also that the mucosal views obtained are clear, facilitating detection of pathologic lesions.
So far no optimal protocol for bowel preparation prior to Capsule endoscopy has been established. Recently, several studies have shown that bowel preparation with polyethylene glycol significantly reduces both gastric and small bowel transit times. Similarly, visualization of the small intestine and therefore 'diagnostic yield' have both been shown to be improved by both sodium phosphate and polyethylene glycol preparation. A more recent study by Selby et al also demonstrates that the prokinetic agent metoclopramide (which is known to promote emptying of the stomach) reduced both stomach and small bowel transit time, increasing completion rates from 76% to 97%).
The proposal is to perform a randomised, controlled study using Citramag and Senna bowel preparation or Metoclopramide to determine whether test completion rates are improved and whether the images of the bowel are of better quality.
The hypothesis is that the improved wall visibility and increased completion rates will improve the diagnostic yield of Capsule endoscopy and therefore improve patient care.
- Being tested
- Senna, Citramag powder, Metoclopramide
- Keywords
- Bowel preparation, capsule endoscopy, randomised, Citramag, Senna, Metoclopramide, Patients referred for Capsule endoscopy, occult/overt gastrointestinal bleeding, other suspected small bowel pathology
- Medical subject headings
- Gastrointestinal Hemorrhage, Anemia, Refractory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SennaDrug
Citramag powderDrug
MetoclopramideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Fraser, MB BCH, MD, FRCP, Principal investigator, St Mark's Hospital, North West London Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275184
- Sponsor's protocol ID
- 05/CE/94
- Other IDs
- REC 05/Q0405/94, EudraCT No: 2005-004423-19
- Status last verified
- Sep 2007
- First submitted
- 10 Jan 2006
- Last updated
- 24 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide
- ClinicalTrials.gov ID
- NCT00275184
- Acronym / sponsor ID
- 05/CE/94
- Keywords
- Bowel preparation, capsule endoscopy, randomised, Citramag, Senna, Metoclopramide, Patients referred for Capsule endoscopy, occult/overt gastrointestinal bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Capsule endoscopy is a diagnostic tool for the detection of small bowel disease allowing noninvasive endoscopic examination of the entire small bowel without the need for sedation. Its limited battery life of 8+/-1 hours means it is paramount that the Capsule reaches the caecum, visualizing the whole of the small intestine, and also that the mucosal views obtained are clear, facilitating detection of pathologic lesions.
So far no optimal protocol for bowel preparation prior to Capsule endoscopy has been established. Recently, several studies have shown that bowel preparation with polyethylene glycol significantly reduces both gastric and small bowel transit times. Similarly, visualization of the small intestine and therefore 'diagnostic yield' have both been shown to be improved by both sodium phosphate and polyethylene glycol preparation. A more recent study by Selby et al also demonstrates that the prokinetic agent metoclopramide (which is known to promote emptying of the stomach) reduced both stomach and small bowel transit time, increasing completion rates from 76% to 97%).
The proposal is to perform a randomised, controlled study using Citramag and Senna bowel preparation or Metoclopramide to determine whether test completion rates are improved and whether the images of the bowel are of better quality.
The hypothesis is that the improved wall visibility and increased completion rates will improve the diagnostic yield of Capsule endoscopy and therefore improve patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 who have been referred for capsule endoscopy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senna | Drug | – |
| Citramag powder | Drug | – |
| Metoclopramide | Drug | – |
Primary outcome
Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel
1 secondary outcome
The tolerance of the bowel preparation to indicate future usage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2007.
Related trials for Small Bowel Disease
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
RecruitingObservational study
Evaluation of Patients With Gastrointestinal Disease
Lower GI Disease, Gastrointestinal Diseases
Active, not recruitingPhase 1/2
Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation
RecruitingPhase 1
Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
Head & Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Fraser, MB BCH, MD, FRCP contact
Neil Patterson, MB BCH, MD, MRCP contact
Christopher Fraser, MB BCH, MD, FRCP principal investigator
St Mark's Hospital, North West London Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Senna, Citramag powder and Metoclopramide in people with Small Bowel Disease and Gastrointestinal Hemorrhage, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Fraser, MB BCH, MD, FRCP (chris.fraser@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007.