WHO ICTRP trial
A Randomized, Double-Blind, Four Treatment, Four Period, Crossover Study, with…
NL-OMON42658 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON42658 |
|---|---|
| Public title | A Randomized, Double-Blind, Four Treatment, Four Period, Crossover Study, with Placebo, Tizanidine Immediate-Release and Diphenhydramine to Study Effect of Tizanidine Extended-Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioning |
| Scientific title | A Randomized, Double-Blind, Four Treatment, Four Period, Crossover Study, with Placebo, Tizanidine Immediate-Release and Diphenhydramine to Study Effect of Tizanidine Extended-Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioning - Tizanidine |
| Primary sponsor | Sun Pharma Advanced Research Company (SPARC) limited |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 2 |
| Countries | The Netherlands |
| Conditions | gezonde proefpersonen; slaperigheid bij rijden na inname medicatie the possible sedative effects of the medication;the possible sedative effects of the medication |
| Interventions | In a crossover design all subjects will receive : - Tizanidine extended release (ER) tablet, (single 12 mg dose) followed by placebo dose after 6.5 hours - Placebo tablet (two doses separated by 6.5 hours) - Diphenhydramine 50 mg tablet… |
| Registration date | Dec 21, 2015 |
| Target size | 24 |
| Secondary IDs | 2015-003770-32;NL54219.028.15 |
| Registry page | onderzoekmetmensen.nl |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: