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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03662113
Other study ID # DomperidoneVCE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date November 1, 2018

Study information

Verified date December 2018
Source Children's Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- Indications of capsule endoscopy;

- Informed consent form obtained.

Exclusion Criteria:

- Contraindication of capsule endoscopy;

- Domperidone allergy;

- Unwilling to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Domperidone
5ml Domperidone prior to VCE
Dietary Supplement:
water
5ml water prior to VCE

Locations

Country Name City State
China Children's hospital of Fudan university Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Completion rate of capsule endoscopy CE was considered complete when the cecum was reached within recording time. assessed through study completion, an average of 1 year
Secondary 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. assessed through study completion, an average of 1 year
Secondary 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. assessed through study completion, an average of 1 year
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