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This trial is a prospective, randomized, feasibility trial with the primary aim of comparing how well oral rapidly dissolving olanzapine controls primary headache pain when compared to the current treatment strategies used in emergency departments which often require intravenous or intramuscular medications.
Primary Question:
Does oral rapidly dissolving olanzapine provide efficacious analgesia in patients with acute headache of non-organic origin (primary headache) who come to the ED for abortive therapy when compared to current standard of care?
Secondary Aim:
Additionally, the study will aim to see if oral rapidly dissolving olanzapine decreases 1) duration of ED length of stay and 2) need for IV access when compared to the current standard of care.
This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | IV Morphine or any medication per attending decision |
|
| Olanzapine | Experimental | oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care as per attending physician | Drug | Patients are randomized to standard of care medication (as determined by attending physician) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Scores Based on Patient Questionnaire | Change in patient reported pain score from baseline using the Numeric Pain Rating Scale (PNRS) Minimum score = 0 Maximum score = 10 Lower score indicates lower pain level, with zero indicating no pain and 10 indicating the worst pain imaginable. | baseline, 30, 60, and 90 minutes post drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Duration of ED Length of Stay | The total time the patient spent in the ED after initially being seen by the physician | Length of Emergency Department stay (Time Frame: up to 12 hours) |
| Number of Participants That Receive Peripheral Intravenous Catheterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Hernandez, MD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician) |
| FG001 | Olanzapine | oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches. 5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline population included is 119 as 5 subjects withdrew after providing informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician) |
| BG001 | Olanzapine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Scores Based on Patient Questionnaire | Change in patient reported pain score from baseline using the Numeric Pain Rating Scale (PNRS) Minimum score = 0 Maximum score = 10 Lower score indicates lower pain level, with zero indicating no pain and 10 indicating the worst pain imaginable. | Not all participants were assessed at each time point due to some being discharged from the Emergency Department prior to study data collection time points. | Posted | Mean | Standard Deviation | units on a scale of 1-10 | baseline, 30, 60, and 90 minutes post drug administration |
|
Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness, lightheadedness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan O'Brien | Regions Hospital | 651-254-5303 | meghan.e.obrien@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2016 | Aug 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.
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Open label, not blinded, randomized 2-arm trial
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| 5mg rapidly dissolving olanzapine | Drug | 5mg rapidly dissolving olanzapine |
|
|
Determining if patients randomized to rapidly dissolving Olanzapine eventually require IV access, defined as A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture |
| Length of Emergency Department stay (Time Frame: up to 12 hours) |
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Olanzapine |
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches. 5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine |
|
|
| Secondary | Comparison of Duration of ED Length of Stay | The total time the patient spent in the ED after initially being seen by the physician | Data was only available for 60 subjects in the standard of care arm and 58 subjects in the olanzapine arm. | Posted | Mean | Standard Deviation | Minutes | Length of Emergency Department stay (Time Frame: up to 12 hours) |
|
|
|
| Secondary | Number of Participants That Receive Peripheral Intravenous Catheterization | Determining if patients randomized to rapidly dissolving Olanzapine eventually require IV access, defined as A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture | Subjects consenting to participate in the study through time of ED discharge with complete data. | Posted | Count of Participants | Participants | Length of Emergency Department stay (Time Frame: up to 12 hours) |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 12 |
| 60 |
| EG001 | Olanzapine | oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches. 5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine | 0 | 59 | 0 | 59 | 11 | 59 |
| Drowsiness | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Burning sensation at IV site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ringing in ears | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Jittery feeling | General disorders | Non-systematic Assessment |
|
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