Olanzapine for Acute Headaches (Olanzapine)
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|ClinicalTrials.gov Identifier: NCT03066622|
Recruitment Status : Completed
First Posted : February 28, 2017
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Headache||Drug: Standard of Care as per attending physician Drug: 5mg rapidly dissolving olanzapine||Phase 4|
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?
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Masking Description:||Open label, not blinded, randomized 2-arm trial|
|Official Title:||Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||May 17, 2018|
|Actual Study Completion Date :||May 20, 2018|
Active Comparator: Standard of Care
IV Morphine or any medication per attending decision
Drug: Standard of Care as per attending physician
Patients are randomized to standard of care medication (as determined by attending physician)
Other Name: standard of care
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
Drug: 5mg rapidly dissolving olanzapine
5mg rapidly dissolving olanzapine
Other Name: Zydis
- Change in Pain Scores Based on Patient Questionnaire [ Time Frame: baseline, 30, 60, and 90 minutes post drug administration ]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.
- Comparison of Duration of ED Length of Stay [ Time Frame: Length of Emergency Department stay (Time Frame: up to 12 hours) ]The total time the patient spent in the ED after initially being seen by the physician
- Number of Participants That Receive Peripheral Intravenous Catheterization [ Time Frame: Length of Emergency Department stay (Time Frame: up to 12 hours) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066622
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55101|
|Principal Investigator:||Bradley Hernandez, MD||HealthPartners Institute|