Paralytic IleusPhase 3EPRUCILNCT04190173
Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus
A Phase 3 study testing Prucalopride in people with Paralytic Ileus and Critically Ill, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paralytic Ileus, Critically Ill
- What is being tested?
- Prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2017to 15 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical patients with APACHE II score >= 15
- Paralytic ileus: small bowel diameter >= 4 cm or large bowel diameter >= 6 cm
Who cannot join
- no current prokinetic use
- Severe peritonitis or bowel inflammation
- ESRD needed hemodialysis
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Prince of Songkla University
Songkhla, 90110
Panu Wetwittayakhlang, Dr., 66867725277, wet.panu@gmail.com
About this study
Official title: Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial
Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events.
Read the detailed description
Prucalopride, a highly selective 5-HT4 receptor agonist, accelerates gastrointestinal transit which may reduce severity of ileus. Furthermore, there is no report of serious cardiac and neurological side effects. We aim to evaluate the efficacy of prucalopride as a prokinetic of choice on paralytic ileus in critically ill patients.
- Conditions
- Paralytic Ileus, Critically Ill
- Being tested
- Prucalopride, Placebo
- Keywords
- Prokinetic, Prucalopride
- Medical subject headings
- Intestinal Pseudo-Obstruction, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Resolor
1-2 mg once daily enteral feeding for 5 consecutive days
PlaceboDrug
1/2-1 tablet once daily enteral feeding for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride | Experimental | Prucalopride (Trade name: Resolor) 2 mg oral or tube feeding once daily 5 consecutive days Decrease dose to 1 mg once daily in patient with end stage kidney disease or Cirrhosis Child Pugh C Receives: Drug: Prucalopride |
| Placebo | Placebo comparator | Placebo tablet to mimic Prucalopride made by starch Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximum bowel diameter from baseline at 24 hours
measure on plain abdominal radiography by blinded radiologist
Measured: after first dose intervention to next 24 hours
Change of maximum bowel diameter from baseline at 48 hours
measure on plain abdominal radiography by blinded radiologist
Measured: after first dose intervention to next 48 hours
Change of maximum bowel diameter from baseline at 72 hours
measure on plain abdominal radiography by blinded radiologist
Measured: after first dose intervention to next 72 hours
Change of maximum bowel diameter from baseline at 96 hours
measure on plain abdominal radiography by blinded radiologist
Measured: after first dose intervention to next 96 hours
Change of maximum bowel diameter from baseline at 120 hours
measure on plain abdominal radiography by blinded radiologist
Measured: after first dose intervention to next 120 hours
Secondary outcomes (5)
change of abdominal circumference from baseline at 24 hours
measured at umbilical level
Measured: after first dose intervention to next 24 hours
change of abdominal circumference from baseline at 48 hours
measured at umbilical level
Measured: after first dose intervention to next 48 hours
change of abdominal circumference from baseline at 72 hours
measured at umbilical level
Measured: after first dose intervention to next 72 hours
change of abdominal circumference from baseline at 96 hours
measured at umbilical level
Measured: after first dose intervention to next 96 hours
change of abdominal circumference from baseline at 120 hours
measured at umbilical level
Measured: after first dose intervention to next 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jul 2017
- Primary completion30 Jan 2020 (estimated)
- Study completion15 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralytic IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consecutive enrolment parallel group in intervention group and placebo group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panu Wetwittayakhlang, Prince of Songkla University
- Investigators
- Sawangpong Jandee, Dr., Principal investigator, Faculty of Medicine, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190173
- Sponsor's protocol ID
- 59-394-14-1
- Acronym
- EPRUCIL
- Status last verified
- Feb 2020
- First submitted
- 2 Dec 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04190173
- Acronym / sponsor ID
- EPRUCIL / 59-394-14-1
- Conditions
- Paralytic Ileus, Critically Ill
- Keywords
- Prokinetic, Prucalopride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 15 Feb 2020 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events.
Detailed description
Prucalopride, a highly selective 5-HT4 receptor agonist, accelerates gastrointestinal transit which may reduce severity of ileus. Furthermore, there is no report of serious cardiac and neurological side effects. We aim to evaluate the efficacy of prucalopride as a prokinetic of choice on paralytic ileus in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Consecutive enrolment parallel group in intervention group and placebo group
| Arm | Type | Receives |
|---|---|---|
| Prucalopride | Experimental | Drug: PrucalopridePrucalopride (Trade name: Resolor) 2 mg oral or tube feeding once daily 5 consecutive days Decrease dose to 1 mg once daily in patient with end stage kidney disease or Cirrhosis Child Pugh C |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet to mimic Prucalopride made by starch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical patients with APACHE II score >= 15
- Paralytic ileus: small bowel diameter >= 4 cm or large bowel diameter >= 6 cm
Key exclusion criteria (3 listed)
- no current prokinetic use
- Severe peritonitis or bowel inflammation
- ESRD needed hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucaloprideAlso: Resolor1-2 mg once daily enteral feeding for 5 consecutive days | Drug | Prucalopride |
| Placebo1/2-1 tablet once daily enteral feeding for 5 consecutive days | Drug | Placebo |
Primary outcome
Change of maximum bowel diameter from baseline at 24 hours
Time frame: after first dose intervention to next 24 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 48 hours
Time frame: after first dose intervention to next 48 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 72 hours
Time frame: after first dose intervention to next 72 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 96 hours
Time frame: after first dose intervention to next 96 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 120 hours
Time frame: after first dose intervention to next 120 hours
measure on plain abdominal radiography by blinded radiologist
5 secondary outcomes
change of abdominal circumference from baseline at 24 hours
Time frame: after first dose intervention to next 24 hours
change of abdominal circumference from baseline at 48 hours
Time frame: after first dose intervention to next 48 hours
change of abdominal circumference from baseline at 72 hours
Time frame: after first dose intervention to next 72 hours
change of abdominal circumference from baseline at 96 hours
Time frame: after first dose intervention to next 96 hours
change of abdominal circumference from baseline at 120 hours
Time frame: after first dose intervention to next 120 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Paralytic Ileus
Not yet recruitingPhase 4
Effect of Preoperative Intrathecal Dexamethasone Versus Dexmedetomidine on Paralytic Ileus After Major Abdominal Surgery
Paralytic Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sawangpong Jandee, Dr. principal investigator
Faculty of Medicine, Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prucalopride in people with Paralytic Ileus and Critically Ill, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panu Wetwittayakhlang, Dr. (66867725277, wet.panu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of maximum bowel diameter from baseline at 24 hours (time frame: after first dose intervention to next 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.