NCT06408714 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

McLaughlin SA, Crandall CS, McKinney PE
Octreotide: an antidote for sulfonylurea-induced hypoglycemia. Ann Emerg Med. 2000 Aug;36(2):133-138. doi: 10.1067/mem.2000.108183.
Newcombe RG
Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998 Apr 30;17(8):873-90. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-i. Erratum In: Stat Med 1999 May 30;18(10):1293.
Wei LJ, Lin DY, Weissfeld L
Regression analysis of multivariate incomplete failure time data by modeling marginal distributions. J Am Stat Assoc. 1989;84:1065-1073.

Comparison of Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection for the Treatment of Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in the Emergency Department

Details for clinical trial NCT06408714

Clinical trial NCT06408714 - References