Acute StrokePhase 4NCT04873297
Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke
A Phase 4 study testing Metoclopramide 10mg in people with Acute Stroke and Aspiration Pneumonia, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Pneumonia is a major cause of mortality and morbidity in patients with acute stroke fed via nasogastric tubes and may be because of vomiting and gastro-esophageal regurgitation. The aim of the study was to assess whether regular treatment with metoclopramide, a D2-receptor antagonist with antiemetic and gastric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Aspiration Pneumonia
- What is being tested?
- Metoclopramide 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2021to 2 Oct 2021
- Phase
- Phase 4
- 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
- Patients of either gender.
- Patients within 7 days of acute ischemic or hemorrhagic stroke confirmed by computed tomographic scan of the brain who required nasogastric feeds for >24 hours, and could be recruited within 48 hours of NGT insertion
- Age above 13 years.
Who cannot join
- Patients with aspiration pneumonia at the time of presentation.
- Patients with a history of chronic neurodegenerative diseases that could affect swallowing (e.g. Parkinson disease and motor neuron disease)
- Poor postural control (unable to sit up for swallowing assessment).
- Esophageal disorders,
- Contraindications to metoclopramide.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, 44000
About this study
Official title: Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke Patients Fed Via Nasogastric Tubes
Pneumonia is a major cause of mortality and morbidity in patients with acute stroke fed via nasogastric tubes and may be because of vomiting and gastro-esophageal regurgitation. The aim of the study was to assess whether regular treatment with metoclopramide, a D2-receptor antagonist with antiemetic and gastric prokinetic actions, could reduce the rate of pneumonia.
Read the detailed description
Patients admitted with no signs of pneumonia within 7 days of stroke onset and 48 hours of insertion of a nasogastric tube will be recruited into a single-blind randomized placebo-controlled study who will admit in Neurology Department, PIMS. Participants will receive metoclopramide 10 mg or placebo 3 times daily via the nasogastric tube for 4 days. Clinical signs of pneumonia will be recorded on alternate days. Pneumonia will be diagnosed if the patient has relevant clinical signs, high inflammatory markers, and new infiltrates on the chest radiograph. A sample size of 106 patients is calculated, 53 patients in each group. Non-probability consecutive sampling will be used for recruitment of participants. Study duration will be six months.
- Conditions
- Acute Stroke, Aspiration Pneumonia
- Being tested
- Metoclopramide 10mg, Placebo
- Medical subject headings
- Stroke, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide 10mgDrug
Also called Metomide, Metoclop
Tab. Metoclopramide 10mg TDS via NG tube
PlaceboDrug
Also called Water
Placebo 10 ml of plain water Via NG
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide Group | Experimental | One group will be given metoclopramide 10mg TDS Receives: Drug: Metoclopramide 10mg |
| Placebo Group | Placebo comparator | This group will be given placebo (normal saline 10ml via NG TDS) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of aspiration pneumonia
Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.
Measured: 7 days
Secondary outcomes (5)
Number of participants with swallowing improved +NGT removed
During admission patient's swallowing with improved and NG tube removed.
Measured: 7 days
Number of participants with treatment withdrawn and NGT removed
Patient's swallowing with improved and treatment withdrawn and NG tube removed.
Measured: 7 days
New onset of Fever
Aspiraton pneumonia will be assess in terms of fever (>98.6F)
Measured: 7 days
Leukocytosis
Aspiration pneumonia will be assess in terms of leukocytosis on blood counts [ TLC >12000/uL]
Measured: 7 days
Aspiration Pneumonia
Treatment with metoclopramide in patients with acute stroke is hypothesized to prevent aspiration pneumonia and pneumonia will be assess in terms of new findings on chest x-ray of patients [The posterior segment of the upper lobes and the superior segment of the lower lobes are most commonly involved lung sites when aspiration occurs in a recumbent patient. In an erect patient, aspiration is more likely to involve bilateral basal segments, middle lobe, and lingula- new exudate, new pleural effusion and new infiltrates]
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start2 May 2021
- Primary completion2 Oct 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After taking permission from the Hospital Ethical Committee this study will be conducted at the Neurology department of PIMS. After informed written consent, all patients admitted to the Neurology ward with acute stroke on the basis of the clinical and radiologic evidence as defined in the operational definition will undergo detailed history and neurological examination. Patients beings grouped into 2 subgroup via lottery method. One group is given metoclopramide and one group will be given placebo (normal saline). SPSS version 23 will be used for data analysis. Post stratification chi square test will be applied. P value ≤0.05 will be considered significant.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Hassan, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Muhammad Hassan, MD, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873297
- Sponsor's protocol ID
- Metoclopramide in Stroke
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke Patients Fed Via Nasogastric Tubes
- ClinicalTrials.gov ID
- NCT04873297
- Acronym / sponsor ID
- Metoclopramide in Stroke
- Conditions
- Acute Stroke, Aspiration Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 2 Oct 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 5 May 2021 (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.
Pneumonia is a major cause of mortality and morbidity in patients with acute stroke fed via nasogastric tubes and may be because of vomiting and gastro-esophageal regurgitation. The aim of the study was to assess whether regular treatment with metoclopramide, a D2-receptor antagonist with antiemetic and gastric prokinetic actions, could reduce the rate of pneumonia.
Detailed description
Patients admitted with no signs of pneumonia within 7 days of stroke onset and 48 hours of insertion of a nasogastric tube will be recruited into a single-blind randomized placebo-controlled study who will admit in Neurology Department, PIMS. Participants will receive metoclopramide 10 mg or placebo 3 times daily via the nasogastric tube for 4 days. Clinical signs of pneumonia will be recorded on alternate days. Pneumonia will be diagnosed if the patient has relevant clinical signs, high inflammatory markers, and new infiltrates on the chest radiograph. A sample size of 106 patients is calculated, 53 patients in each group. Non-probability consecutive sampling will be used for recruitment of participants. Study duration will be six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After taking permission from the Hospital Ethical Committee this study will be conducted at the Neurology department of PIMS. After informed written consent, all patients admitted to the Neurology ward with acute stroke on the basis of the clinical and radiologic evidence as defined in the operational definition will undergo detailed history and neurological examination. Patients beings grouped into 2 subgroup via lottery method. One group is given metoclopramide and one group will be given placebo (normal saline). SPSS version 23 will be used for data analysis. Post stratification chi square test will be applied. P value ≤0.05 will be considered significant.
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide Group | Experimental | Drug: Metoclopramide 10mgOne group will be given metoclopramide 10mg TDS |
| Placebo Group | Placebo comparator | Drug: PlaceboThis group will be given placebo (normal saline 10ml via NG TDS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either gender.
- Patients within 7 days of acute ischemic or hemorrhagic stroke confirmed by computed tomographic scan of the brain who required nasogastric feeds for >24 hours, and could be recruited within 48 hours of NGT insertion
- Age above 13 years.
Key exclusion criteria (5 listed)
- Patients with aspiration pneumonia at the time of presentation.
- Patients with a history of chronic neurodegenerative diseases that could affect swallowing (e.g. Parkinson disease and motor neuron disease)
- Poor postural control (unable to sit up for swallowing assessment).
- Esophageal disorders,
- Contraindications to metoclopramide.
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 |
|---|---|---|
| Metoclopramide 10mgAlso: Metomide, MetoclopTab. Metoclopramide 10mg TDS via NG tube | Drug | Metoclopramide Group |
| PlaceboAlso: WaterPlacebo 10 ml of plain water Via NG | Drug | Placebo Group |
Primary outcome
Number of episodes of aspiration pneumonia
Time frame: 7 days
Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.
5 secondary outcomes
Number of participants with swallowing improved +NGT removed
Time frame: 7 days
Number of participants with treatment withdrawn and NGT removed
Time frame: 7 days
New onset of Fever
Time frame: 7 days
Leukocytosis
Time frame: 7 days
Aspiration Pneumonia
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Muhammad Hassan, MD principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoclopramide 10mg in people with Acute Stroke and Aspiration Pneumonia, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 19 Oct 2021. 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes of aspiration pneumonia (time frame: 7 days). 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 19 Oct 2021.