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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

Tracking Information
First Submitted Date  ICMJE September 4, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date December 17, 2018
Actual Study Start Date  ICMJE November 1, 2017
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy
Official Title  ICMJE Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Capsule Endoscopy
  • Pediatric Disorder
Intervention  ICMJE
  • Drug: Domperidone
    5ml Domperidone prior to VCE
    Other Name: simethicone
  • Dietary Supplement: water
    5ml water prior to VCE
    Other Name: simethicone
Study Arms  ICMJE
  • Experimental: Experimental: Domperidone
    5ml domperidone prior to VCE
    Intervention: Drug: Domperidone
  • Control: water
    5ml warm water prior to VCE
    Intervention: Dietary Supplement: water
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
402
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication of capsule endoscopy;
  • Domperidone allergy;
  • Unwilling to participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662113
Other Study ID Numbers  ICMJE DomperidoneVCE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ying HUANG, Children's Hospital of Fudan University
Study Sponsor  ICMJE Children's Hospital of Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ying Huang, doctor Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP