NCT04104867

Brief Summary

colonoscopy has been a preferred modality for colorectal screening which efficiently reduce in morbidity and mortality of the disaese. Although colonoscopy is a safe procedure, some patients may be suffered from major and minor complications. Abdominal discomfort (approximately 30%) usually persisted for 2 days after colonoscopy. These unsatisfactory experiences might affect the patients' willingness to return for a repeat colonoscopy, which the loss of adherence eventually reduce the effectiveness of colorectal cancer screening and surveillance. Furthermore, during colonoscopy preparation, the patients are required to take large volume Polyethylene glycol-electrolyte lavage (PEG-EL) solution for bowel preparation which possibly lead to unpleasant gastrointestinal symptoms likewise. Prokinetic agents are a class of drugs that promoted gastrointestinal motility and, thereby, decrease transit time. This stimulatory effect was considered clinically relevant to the management of disorders characterized by impaired motility, such as gastro-esophageal reflux, gastroparesis, intestinal pseudo-obstruction, and colonic inertia. Prokinetic agents have various mechanism such as Cholinergic agonists, Dopamine antagonists (i.e.Domperidone, Metoclopramide), Serotonergic agonists (i.e. Cisapride, Prucalopride,Mosapride). Interestingly, these drugs have been used to minimize the unpleasant abdominal symptoms from colonoscopy. The objective of this study is to examine the efficacy of a prokinetic agent in alleviating abdominal discomfort during the period of colonoscopy preparation and aftercolonoscopy consecutively.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
525

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

3.1 years

First QC Date

September 17, 2019

Last Update Submit

September 1, 2021

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • abdominal pain

    the severity of abdominal pain using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)

    24 hour

Secondary Outcomes (2)

  • abdominal pain

    48 hour

  • abdominal pain

    72 hour

Study Arms (3)

Colonoscopy preparation by PEG-EL with Itopride

ACTIVE COMPARATOR

Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.

Drug: Itopride

Colonoscopy preparation by PEG-EL with Placebo

PLACEBO COMPARATOR

Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.

Other: Placebo

Colonoscopy preparation by PEG-EL with Domperidone

ACTIVE COMPARATOR

Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.

Drug: Domperidone

Interventions

ItoprideDRUG

the patients are instructed to take one pill of Itopride at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.

Also known as: Colonoscopy preparation by PEG-EL with Itopride
Colonoscopy preparation by PEG-EL with Itopride
DomperidoneDRUG

the patients are instructed to take one pill of Domperidone at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.

Also known as: Colonoscopy preparation by PEG-EL with Domperidone
Colonoscopy preparation by PEG-EL with Domperidone
PlaceboOTHER

the patients are instructed to take one pill of placebo at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.

Also known as: Colonoscopy preparation by PEG-EL with Placebo
Colonoscopy preparation by PEG-EL with Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are an outpatient scheduled for elective colonoscopy at Ramathibodi hospital
  • Age between 18 to 80 years old
  • American Society of Anesthesiologists (ASA) classification 1-2

You may not qualify if:

  • Patients who reject to participate or withdrawal from the research
  • History of Domperidone or Itopride allergy
  • Patients who do not complete taking the study medication
  • Patients who have ostomy or history of subtotal colectomy
  • Patients who are diagnosed active colitis i.e. ulcerative colitis, TB colitis
  • Take any pain reliever agent during the study period
  • Patients who are unable to communicate comprehensibly
  • Severe renal or hepatic impairment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

Related Publications (5)

  • Quigley EMM. Prokinetics in the Management of Functional Gastrointestinal Disorders. Curr Gastroenterol Rep. 2017 Sep 8;19(10):53. doi: 10.1007/s11894-017-0593-6.

    PMID: 28887755BACKGROUND

  • Panteris V, Haringsma J, Kuipers EJ. Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy. 2009 Nov;41(11):941-51. doi: 10.1055/s-0029-1215179. Epub 2009 Oct 28.

    PMID: 19866393RESULT

  • de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.

    PMID: 22391645RESULT

  • Pignone M, Saha S, Hoerger T, Mandelblatt J. Cost-effectiveness analyses of colorectal cancer screening: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Jul 16;137(2):96-104. doi: 10.7326/0003-4819-137-2-200207160-00007.

    PMID: 12118964RESULT

  • Mishima Y, Amano Y, Okita K, Takahashi Y, Moriyama N, Ishimura N, Furuta K, Ishihara S, Adachi K, Kinoshita Y. Efficacy of prokinetic agents in improving bowel preparation for colonoscopy. Digestion. 2008;77(3-4):166-72. doi: 10.1159/000141040. Epub 2008 Jun 25.

    PMID: 18577886RESULT

MeSH Terms

Conditions

Abdominal Pain

Interventions

itoprideDomperidone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chairat Supsamutchai, MD

    Ramathibodi Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The participants will be randomly selected into one of the three arms (1:1:1 ratio) of a sealed, opaque envelope by one of the surgical residents or by the attending surgeon. The participants in each group will receive an envelope containing pills of identical appearance, each of Domperidone 10 mg, Itopride 50 mg or placebo. Both the attending physicians and the participants are blinded to the kind of study medication contained in the envelope. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy. At the colonoscopy unit, the patients will be interviewed regarding the severity of abdominal discomfort during the preparation period after consuming the 3 liters of PEG-EL using a numeric pain rating scale.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 26, 2019

Study Start

September 16, 2019

Primary Completion

October 30, 2022

Study Completion

February 1, 2023

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)