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Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662113
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ying HUANG, Children's Hospital of Fudan University

Brief 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.

Condition or disease Intervention/treatment Phase
Capsule Endoscopy Pediatric Disorder Drug: Domperidone Dietary Supplement: water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Experimental: Domperidone
5ml domperidone prior to VCE
Drug: Domperidone
5ml Domperidone prior to VCE
Other Name: simethicone

Control: water
5ml warm water prior to VCE
Dietary Supplement: water
5ml water prior to VCE
Other Name: simethicone




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Gastric transit time (GTT) [ Time Frame: assessed through study completion, an average of 1 year ]
    The GTT was defined as the time, in minutes, from the first image of the stomach until the first image of the duodenum.

  2. small bowel transit time (SBTT) [ Time Frame: assessed through study completion, an average of 1 year ]
    The SBTT was defined as the passage time, in minutes, from the first image of the duodenum until the first image of the cecum.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indications of capsule endoscopy;
  • Informed consent form obtained.

Exclusion Criteria:

  • Contraindication of capsule endoscopy;
  • Domperidone allergy;
  • Unwilling to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662113


Locations
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China, Shanghai
Children's hospital of Fudan university
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Director: Ying Huang, doctor Children's Hospital of Fudan University
Publications:
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Responsible Party: Ying HUANG, The director of gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03662113    
Other Study ID Numbers: DomperidoneVCE
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ying HUANG, Children's Hospital of Fudan University:
domperidone
Additional relevant MeSH terms:
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Domperidone
Simethicone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antifoaming Agents
Emollients
Dermatologic Agents