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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04583111
Other study ID # RJYYXHNK-006
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2020
Est. completion date March 1, 2022

Study information

Verified date September 2020
Source RenJi Hospital
Contact Shengliang Chen, Dr
Phone 02158752345
Email slchenmd@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 18-70 years patients scheduled for colonoscopy

Exclusion Criteria:

- intestinal obstruction or hemorrhage;

- allergy to domperidone, sulpiride or PEG;

- pregnancy or breastfeeding;

- previous use of prokinetics within 1 month.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Domperidone
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
sulpiride
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.

Locations

Country Name City State
China Shengliang Chen Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of the discomforts during bowel preparation The primary endpoint of this study was the discomforts during bowel preparation such as nausea, vomit, abdominal fullness and pain. These symptoms were assessed as none, mild, moderate and severe. Patients with mild to severe symptoms were classified as presence of discomforts. before colonoscopy
Secondary The quality of bowel preparation assessed by Boston Bowel Preparation Scale The secondary endpoint was the quality of bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS) during the withdrawal phase of colonoscopy. The BBPS uses a 0-3 points scale assessing the bowel preparation quality in 3 segments of the colon (the right, transverse and left colons). BBPS score = 6 were defined as adequate bowel preparation. during colonoscopy
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