WHO ICTRP trial
Efficacy and Safety in a randomised acute pain study of MR308.
EUCTR2016-000592-24-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-000592-24-DE |
|---|---|
| Public title | Efficacy and Safety in a randomised acute pain study of MR308. |
| Scientific title | A Randomized, Double-Blind, Multicenter, Placebo- and active Comparator-Controlled Study to evaluate Efficacy and Safety of MR308 in the Treatment of Acute Pain After Third Molar Tooth Extraction (STARDOM1). - STARDOM1 |
| Primary sponsor | Mundipharma Research GmbH & Co. KG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Hungary;Canada;Poland;Spain;Germany;Italy |
| Conditions | Acute pain after third molar tooth extraction; dental procedure must have involved extraction of at least two impacted third molars requireing bone removal. If only two impacted third molars are extracted, they must be ipsilateral and both… |
| Interventions | Product Name: MR308 Tablet 100 mg Pharmaceutical Form: Tablet INN or Proposed INN: Tramadol hydrochloride Celecoxib Current Sponsor code: MR308 Co-crystal Other descriptive name: CTC cocrystal Concentration unit: mg milligram(s)… |
| Registration date | Dec 8, 2016 |
| Target size | 765 |
| Secondary IDs | MR308-3501 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: