Histamine Glutamate Antagonism in Stroke
Keywords
Abstract
Description
If the subject decides to take part in this study, the subject will be placed randomly in the treatment group or the standard of care group. This means:
The subject will be given either the treatment drugs with standard of care for stroke or only standard of care. If the subject is placed in the treatment group the subject will be again randomly administered either diphenhydramine oral or through an injection in the vein for 4 days or dextromethorphan tablet orally for 2 days. In the treatment group the subject will receive another drug named famotidine through an injection in vein as a prophylaxis to prevent any gastrointestinal bleeding or ulceration whereas in the standard of care group the subject will receive pantoprazole through an injection in the vein for the same purpose. If the subject cannot take medication orally then we will put a tube through the nose to the subject's stomach or small intestine or we might also put a gastric tube directly into the subject's stomach surgically through a small cut in the belly. The investigators will collect information for the medical charts to include: imaging data, stroke assessments and medical history. A neurological exam will done, called the National Institutes of Health Stroke Scale (NIHSS). It is used to assess the neurologic damage caused by stroke. A Modified Rankin Scale (m-RS) will also be performed and this is a scale used to measure the degree of disability or dependence in the daily activities after a stroke.
The subject will be asked to come for a follow-up at 3 months after the discharge from the hospital and the following will be done:
1. Modified Rankin Scale (m-RS) scores NIH Stroke Scale scores
2. CT or MRI of the head without contrast
Dates
| Last Verified: | 10/31/2015 |
| First Submitted: | 05/08/2014 |
| Estimated Enrollment Submitted: | 05/14/2014 |
| First Posted: | 05/19/2014 |
| Last Update Submitted: | 11/09/2015 |
| Last Update Posted: | 12/14/2015 |
| Date of first submitted results: | 09/22/2015 |
| Date of first submitted QC results: | 11/09/2015 |
| Date of first posted results: | 12/14/2015 |
| Actual Study Start Date: | 11/30/2014 |
| Estimated Primary Completion Date: | 11/30/2014 |
| Estimated Study Completion Date: | 11/30/2014 |
Condition or disease
Intervention/treatment
Drug: Diphenhydramine
Drug: Pantoprazole
Drug: Famotidine
Drug: Dextromethorphan
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Pantoprazole Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care. | Drug: Pantoprazole Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care. |
| Active Comparator: Famotidine Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care. | |
| Experimental: Dextromethorphan Dextromethorphan 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) along with current standard of care.
If the drug can't be given orally, then feeding tube (G-tube, NG Tube or DHT) will be used for drug administration. | Drug: Dextromethorphan Dextromethorphan 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) along with current standard of care. If the drug can't be given orally, then feeding tube (G-tube, NG Tube or DHT) will be used for drug administration. |
| Experimental: Diphenhydramine Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. | Drug: Diphenhydramine Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Subjects with age ≥18 years and ≤80 years at the time of screening. 2. All Ischemic stroke patients with clinical and or radiological diagnosis. 3. Subjects who have presented to hospital within 6 hours of symptom onset. 4. The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study. Exclusion Criteria: 1. Subject with age < 18 years and >80 years at the time of screening. 2. Time of symptom onset cannot be determined. 3. Subject who is pregnant or lactating. 4. Subject who has asthma exacerbations in past 3 months. 5. Subject who has hypersensitivity to dextromethorphan, diphenhydramine or famotidine, or other H2 antagonists or any component of the formulation. 6. Serotonin syndrome. 7. Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor 8. Subjects with renal or hepatic failure. 9. The subject or legal representative is unable to provide informed consent. 10. The subject is medically unstable to participate in the trial as determined by the principal investigator. 11. The subject has any end stage medical condition as determined by the principal investigator. |
Outcome
Primary Outcome Measures
1. Modified Rankin Score [8 days and 3 months from the baseline]
2. National Institutes of Health Stroke Severity (NIHSS) Scale [Baseline]
3. Glasgow Coma Scale (GCS) [Baseline]
4. Barthel Index [At 3 months from baseline]
Other Outcome Measures
1. CT or MRI of Head Without Contrast [At 3 months from baseline]
