Efficacy and Safety of Zolmitriptan by Sublingual Administration
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|ClinicalTrials.gov Identifier: NCT03377257|
Recruitment Status : Unknown
Verified May 2017 by Xijing Hospital.
Recruitment status was: Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cluster Headache||Drug: zolmitriptan by sublingual administration Drug: zolmitriptan by oral||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||71 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||April 30, 2019|
Active Comparator: Active group
The treatment with oral zolmitriptan is 2.5mg when headache attack.
Drug: zolmitriptan by oral
Experimental: Experimental group
The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.
Drug: zolmitriptan by sublingual administration
Other Name: zolmitriptan
- The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet [ Time Frame: 5, 10, 15 minutes after administration ]The difference of the percentage of the headache attacks whose visual analogue scale points reduce from 7-10 to 0-3 5, 10, 15 minutes after administration between sublingual and oral zolmitriptan tablet
- The percentage of side effects; [ Time Frame: 3 hours ]The difference of the percentage of side effects in 3 hours after the administration between sublingual and oral zolmitriptan tablet
- The percentage of discontinued the drug [ Time Frame: 3 days ]The percentage of discontinued the drug because of side effects
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): NCT03377257
|Contact: Li Li, MDemail@example.com|
|Contact: Li li, MDfirstname.lastname@example.org|
|Principal Investigator:||Li Li, MD||Xijing Hospital|