Anticholinesterase Insecticide PoisoningPhase 3CCBOCNCT03925025
Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning
A Phase 3 study testing Magnesium Sulfate and Nimodipine in people with Anticholinesterase Insecticide Poisoning and Pesticide Poisoning, run by University of Edinburgh at 7 sites in Bangladesh.
Trial summary
This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anticholinesterase Insecticide Poisoning, Pesticide Poisoning
- What is being tested?
- Magnesium Sulfate and Nimodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,728 participants
- Where
- 7 sitesBangladesh
- Study dates
- 11 Jun 2020to 30 Apr 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 16 years or older with suspected OP or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine.
- Diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. The insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. WhatsApp.
- Patients who ingest combination products containing OP or carbamate insecticides will also be included.
- Inhibited blood cholinesterase activity as shown by routine clinical bedside test
Who cannot join
- Children aged <16 years.
- Patients who do not require atropine and have not had it prior to presentation during this episode.
- Normal blood cholinesterase activity
- Self-reported known pregnancy (as per South Asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response)
- Known occupational and homicidal poisoning
- Past medical history of severely impaired renal function
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- Hypersensitivity to magnesium and its salts
- Patients who have had a myocardial infarction or unstable angina in the last month
- Patients with traumatic subarachnoid haemorrhage
- Lack of informed consent (unaccompanied unconscious patients and others)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Bangladesh7 sites
Shaheed Ziaur Rahman Medical College
Bogura, Silimpur, 5800
Chattogram Medical College Hospital
Chittagong, 4203
Jashore Medical College Hospital
Jessore
Khulna Medical College Hospital
Khulna
Rajshahi Medical College Hospital
Rajshahi, Rajshahi Division, 6100
Rangpur Medical College Hospital
Rangpur City
Sylhet MAG Osmani Medical College Hospital
Sylhet
About this study
Official title: Effectiveness of Calcium Channel Blockade for Organophosphorus and Carbamate Pesticide Poisoning - an Open, Pragmatic, 3-arm RCT Repurposing Two Widely Available Licensed Medicines
This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.
- Being tested
- Magnesium Sulfate, Nimodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Treatment in addition to standard therapy
NimodipineDrug
Treatment in addition to standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard therapy |
| Magnesium sulfate | Active comparator | Standard therapy plus magnesium sulfate Receives: Drug: Magnesium Sulfate |
| Nimodipine | Active comparator | Standard therapy plus nimodipine Receives: Drug: Nimodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Whether dead or alive at hospital discharge
Measured: through to hospital discharge, median 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start11 Jun 2020
- Primary completion31 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anticholinesterase Insecticide PoisoningStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,728 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Toxicology Society of Bangladesh
- Responsible party
- Sponsor
- Investigators
- Dr Fazle Rabbi Chowdhury, MD, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925025
- Sponsor's protocol ID
- AC19003
- Acronym
- CCBOC
- Status last verified
- Oct 2024
- First submitted
- 17 Apr 2019
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Brvar M, Chan MY, Dawson AH, Ribchester RR, Eddleston M. Magnesium sulfate and calcium channel blocking drugs as antidotes for acute organophosphorus insecticide poisoning - a systematic review and meta-analysis. Clin Toxicol (Phila). 2018 Aug;56(8):725-736. doi: 10.1080/15563650.2018.1446532. Epub 2018 Mar 20.
PubMed 29557685
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Calcium Channel Blockade for Organophosphorus and Carbamate Pesticide Poisoning - an Open, Pragmatic, 3-arm RCT Repurposing Two Widely Available Licensed Medicines
- ClinicalTrials.gov ID
- NCT03925025
- Acronym / sponsor ID
- CCBOC / AC19003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,728 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Toxicology Society of Bangladesh
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 23 Apr 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.
This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard therapy |
| Magnesium sulfate | Active comparator | Drug: Magnesium SulfateStandard therapy plus magnesium sulfate |
| Nimodipine | Active comparator | Drug: NimodipineStandard therapy plus nimodipine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 16 years or older with suspected OP or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine.
- Diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. The insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. WhatsApp.
- Patients who ingest combination products containing OP or carbamate insecticides will also be included.
- Inhibited blood cholinesterase activity as shown by routine clinical bedside test
Key exclusion criteria (10 listed)
- Children aged <16 years.
- Patients who do not require atropine and have not had it prior to presentation during this episode.
- Normal blood cholinesterase activity
- Self-reported known pregnancy (as per South Asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response)
- Known occupational and homicidal poisoning
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 |
|---|---|---|
| Magnesium SulfateTreatment in addition to standard therapy | Drug | Magnesium sulfate |
| NimodipineTreatment in addition to standard therapy | Drug | Nimodipine |
Primary outcome
Mortality
Time frame: through to hospital discharge, median 1 week
Whether dead or alive at hospital discharge
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 1 Oct 2025.
- Background: PubMed 29557685Brvar M, Chan MY, Dawson AH, Ribchester RR, Eddleston M. Magnesium sulfate and calcium channel blocking drugs as antidotes for acute organophosphorus insecticide poisoning - a systematic review and meta-analysis. Clin Toxicol (Phila). 2018 Aug;56(8):725-736. doi: 10.1080/15563650.2018.1446532. Epub 2018 Mar 20.
- Individual participant dataSharing planned: Yes
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.
Dr Fazle Rabbi Chowdhury, MD principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Sulfate and Nimodipine in people with Anticholinesterase Insecticide Poisoning and Pesticide Poisoning, run by University of Edinburgh at 7 sites in Bangladesh.
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 4 inclusion and 10 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Bangladesh. 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. 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?
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?
Mortality (time frame: through to hospital discharge, median 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03925025, which also lists 1 linked publication.
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 1 Oct 2025.