WHO ICTRP trial
SYNERGY OSA
CTIS2023-510519-20-00 · EU Clinical Trials Information System · Not Recruiting
Key facts
| Trial ID | CTIS2023-510519-20-00 |
|---|---|
| Public title | SYNERGY OSA |
| Scientific title | SYNERGY OSA - EFFICACY, SAFETY and TOLERABILITY OF COMBINED THERAPY WITH A SOMNOMED ORAL APPLIANCE AND THE CARBONIC ANHYDRASE INHIBITOR SULTHIAME IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA. A Randomized, Double-Blind, Placebo Controlled, Proof-of-Concept Trial |
| Primary sponsor | Vaestra Goetalandsregionen |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): Yes Therapeutic confirmatory - (Phase III): No Therapeutic use - (Phase IV): No |
| Countries | Denmark;Sweden |
| Conditions | Obstructive sleep apnea with an incomplete clinical response to oral appliance therapy. MedDRA version: 25.0Level: LLTClassification code: 10055577Term: Obstructive sleep apnea syndrome Class: 10038738;Therapeutic area: Diseases [C]… |
| Interventions | Product Name: Placebo - same composition as IMP except for the active substance, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Ospolot 50 mg… |
| Registration date | Jun 14, 2024 |
| Target size | 50 |
| Registry page | euclinicaltrials.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: