Capsule EndoscopyNCT03662113
Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy
A study testing Domperidone and water in people with Capsule Endoscopy and Pediatric Disorder, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Capsule Endoscopy, Pediatric Disorder
- What is being tested?
- Domperidone and water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Nov 2018
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Indications of capsule endoscopy;
- Informed consent form obtained.
Who cannot join
- Contraindication of capsule endoscopy;
- Domperidone allergy;
- Unwilling to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.
Read the detailed description
Eligible children were randomly divided into two groups: domperidone prior to VCE and water prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures included the GTT and SBTT.
- Conditions
- Capsule Endoscopy, Pediatric Disorder
- Being tested
- Domperidone, water
- Keywords
- domperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
Also called simethicone
5ml Domperidone prior to VCE
waterDietary supplement
Also called simethicone
5ml water prior to VCE
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Domperidone | Experimental | 5ml domperidone prior to VCE Receives: Drug: Domperidone |
| Control: water | Other | 5ml warm water prior to VCE Receives: Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of capsule endoscopy
CE was considered complete when the cecum was reached within recording time.
Measured: assessed through study completion, an average of 1 year
Secondary outcomes (2)
Gastric transit time (GTT)
The GTT was defined as the time, in minutes, from the first image of the stomach until the first image of the duodenum.
Measured: assessed through study completion, an average of 1 year
small bowel transit time (SBTT)
The SBTT was defined as the passage time, in minutes, from the first image of the duodenum until the first image of the cecum.
Measured: assessed through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Nov 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Capsule EndoscopyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- Ying Huang, doctor, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662113
- Sponsor's protocol ID
- DomperidoneVCE
- Status last verified
- Dec 2018
- First submitted
- 4 Sep 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mcfarlane M, Liu B, Nwokolo C. Domperidone prolongs oral to duodenal transit time in video capsule endoscopy. Eur J Clin Pharmacol. 2018 Apr;74(4):521-524. doi: 10.1007/s00228-017-2399-8. Epub 2017 Dec 8.
PubMed 29222714Wu J, Ye Z, Xue A, Huang Y. Can domperidone decrease transit time of pediatric video capsule endoscopy? A randomized controlled trial. Transl Pediatr. 2021 Feb;10(2):344-349. doi: 10.21037/tp-20-273.
PubMed 33708520
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03662113
- Acronym / sponsor ID
- DomperidoneVCE
- Conditions
- Capsule Endoscopy, Pediatric Disorder
- Keywords
- domperidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 7 Sep 2018 (actual)
- 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.
Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.
Detailed description
Eligible children were randomly divided into two groups: domperidone prior to VCE and water prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures included the GTT and SBTT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Domperidone | Experimental | Drug: Domperidone5ml domperidone prior to VCE |
| Control: water | Other | Dietary Supplement: water5ml warm water prior to VCE |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Indications of capsule endoscopy;
- Informed consent form obtained.
Key exclusion criteria (3 listed)
- Contraindication of capsule endoscopy;
- Domperidone allergy;
- Unwilling to participate.
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 |
|---|---|---|
| DomperidoneAlso: simethicone5ml Domperidone prior to VCE | Drug | Experimental: Domperidone |
| waterAlso: simethicone5ml water prior to VCE | Dietary supplement | Control: water |
Primary outcome
Completion rate of capsule endoscopy
Time frame: assessed through study completion, an average of 1 year
CE was considered complete when the cecum was reached within recording time.
2 secondary outcomes
Gastric transit time (GTT)
Time frame: assessed through study completion, an average of 1 year
small bowel transit time (SBTT)
Time frame: assessed through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Background: PubMed 29222714Mcfarlane M, Liu B, Nwokolo C. Domperidone prolongs oral to duodenal transit time in video capsule endoscopy. Eur J Clin Pharmacol. 2018 Apr;74(4):521-524. doi: 10.1007/s00228-017-2399-8. Epub 2017 Dec 8.
- Derived from this study: PubMed 33708520Wu J, Ye Z, Xue A, Huang Y. Can domperidone decrease transit time of pediatric video capsule endoscopy? A randomized controlled trial. Transl Pediatr. 2021 Feb;10(2):344-349. doi: 10.21037/tp-20-273.
- Individual participant dataSharing planned: No
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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.
Ying Huang, doctor study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domperidone and water in people with Capsule Endoscopy and Pediatric Disorder, run by Children's Hospital of Fudan University at 1 site in China.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 17 Dec 2018. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate of capsule endoscopy (time frame: assessed through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662113, which also lists 2 linked publications.
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 17 Dec 2018.