Acute Agitated PatientsPhase 3NCT00290082
Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
A Phase 3 study testing loxapine, midazolam, blood sample and patient monitoring in people with Acute Agitated Patients, run by University Hospital, Rouen at 21 sites in France.
Trial summary
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication. However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Agitated Patients
- What is being tested?
- loxapine, midazolam, blood sample and patient monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 21 sitesFrance
- Study dates
- Dec 2005to Oct 2007
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old
Who cannot join
- Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Emergency Department
Agen, 47923
Emergecy department
Argenteuil, 95100
Emergency Department
Bayeux, 74401
Emergency Department
Bondy, 93143
Emergency Department
Carcassonne, 11890
Emergency Department
Clermont-Ferrand, 63003
Emergency Department
Créteil, Paris
Emergency Department
Dijon, 11890
Emergency Department
Elbeuf, 76503
Emergency Department
Ghps, Paris
Emergency Department
Grenoble, 38043
Emergency Department
Le Havre
Emergency Department
Le Kremlin-Bicêtre, 94275
Emergency Department
Le Mans, 72037
Emergency Department
Lisieux, 97223
Emergency Department
Montauban, 82013
Emergency Department
Nantes, 44093
Emergency Department
Pontoise, 95301
Emergency Department
Raincy-Montfermeil, 93370
Emergency Department
Roanne, 43328
Emergency Department
Saint-Etienne, 42055
About this study
Official title: Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.
However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.
The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.
Read the detailed description
Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)
- Conditions
- Acute Agitated Patients
- Being tested
- loxapine, midazolam, blood sample, patient monitoring, Loxapine, Midazolam
- Keywords
- sedation, midazolam, loxapine, agitation, emergency department, toxicological analysis
- Medical subject headings
- Psychomotor Agitation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loxapine, midazolamDrug
Also called Loxapac, Hypnovel
agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
blood sampleBiological
Also called Loxapac, Hypnovel
was evaluated in patients sedated, alcohol level, blood sugar
patient monitoringOther
Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
LoxapineDrug
Loxapine 1 mL / 10 kg
MidazolamDrug
Midazolam 1 mL / 10 Kg
| Study group | Role | What they receive |
|---|---|---|
| loxapine | Active comparator | agitated patients were randomly assigned either to loxapine, either to midazolam group Receives: Drug: loxapine, midazolam; Biological: blood sample; Other: patient monitoring; Drug: Loxapine |
| midazolam | Active comparator | midazolam is compared to loxapine in terms of efficacy and tolerance Receives: Drug: loxapine, midazolam; Biological: blood sample; Other: patient monitoring; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of treatment at 20 min
Measured: 20 min
Secondary outcomes (5)
Success of treatment at 40 and 60 min
Measured: 40 and 60 mn
Agitation level at 20,40 and 60 min
Measured: 20, 40 and 60mn
Need for rescue medication
Measured: any time
Sedation duration
treatment failure
Measured: one hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: 2 complications with midazolam
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Agitated PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Investigators
- Fabienne FM Moritz, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290082
- Sponsor's protocol ID
- 2004/055/HP
- Other IDs
- French state grant
- Status last verified
- Mar 2015
- First submitted
- 9 Feb 2006
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT00290082
- Acronym / sponsor ID
- 2004/055/HP
- Conditions
- Acute Agitated Patients
- Keywords
- sedation, midazolam, loxapine, agitation, emergency department, toxicological analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 2 complications with midazolam
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 10 Feb 2006 (estimated)
- 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.
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.
However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.
The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.
Detailed description
Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| loxapine | Active comparator | Drug: loxapine, midazolam, Biological: blood sample, Other: patient monitoring, Drug: Loxapineagitated patients were randomly assigned either to loxapine, either to midazolam group |
| midazolam | Active comparator | Drug: loxapine, midazolam, Biological: blood sample, Other: patient monitoring, Drug: Midazolammidazolam is compared to loxapine in terms of efficacy and tolerance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old
Key exclusion criteria (1 listed)
- Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital
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 |
|---|---|---|
| loxapine, midazolamAlso: Loxapac, Hypnovelagitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml) | Drug | loxapine, midazolam |
| blood sampleAlso: Loxapac, Hypnovelwas evaluated in patients sedated, alcohol level, blood sugar | Biological | loxapine, midazolam |
| patient monitoringTill his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected. | Other | loxapine, midazolam |
| LoxapineLoxapine 1 mL / 10 kg | Drug | loxapine |
| MidazolamMidazolam 1 mL / 10 Kg | Drug | midazolam |
Primary outcome
Success of treatment at 20 min
Time frame: 20 min
5 secondary outcomes
Success of treatment at 40 and 60 min
Time frame: 40 and 60 mn
Agitation level at 20,40 and 60 min
Time frame: 20, 40 and 60mn
Need for rescue medication
Time frame: any time
Sedation duration
treatment failure
Time frame: one hour after treatment
Results and safety
The study was stopped early (reason given: 2 complications with midazolam). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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.
Fabienne FM Moritz, MD principal investigator
University Hospital, Rouen
21 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 loxapine, midazolam, blood sample and patient monitoring in people with Acute Agitated Patients, run by University Hospital, Rouen at 21 sites in France.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. 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 was stopped early (reason given: 2 complications with midazolam). Results are not available in the source record.
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?
Success of treatment at 20 min (time frame: 20 min). 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 11 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.