NCT01338935 - 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)

Belmont MR, Lien CA, Tjan J, Bradley E, Stein B, Patel SS, Savarese JJ
Clinical pharmacology of GW280430A in humans. Anesthesiology. 2004 Apr;100(4):768-73.
Donati F
Neuromuscular blocking drugs for the new millennium: current practice, future trends--comparative pharmacology of neuromuscular blocking drugs. Anesth Analg. 2000 May;90(5 Suppl):S2-6. Review.
Kopman AF, Klewicka MM, Neuman GG
An alternate method for estimating the dose-response relationships of neuromuscular blocking drugs. Anesth Analg. 2000 May;90(5):1191-7. Erratum in: Anesth Analg 2000 Jul;91(1):67.
Kopman AF, Klewicka MM, Neuman GG
Reexamined: the recommended endotracheal intubating dose for nondepolarizing neuromuscular blockers of rapid onset. Anesth Analg. 2001 Oct;93(4):954-9.
Savarese JJ, McGilvra JD, Sunaga H, Belmont MR, Van Ornum SG, Savard PM, Heerdt PM
Rapid chemical antagonism of neuromuscular blockade by L-cysteine adduction to and inactivation of the olefinic (double-bonded) isoquinolinium diester compounds gantacurium (AV430A), CW 002, and CW 011. Anesthesiology. 2010 Jul;113(1):58-73. doi: 10.1097/ALN.0b013e3181dc1b5b.
Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D
Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. Review.

A Phase I, Single-Site, Tri-Institutional, Open-Label, Three-Part, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of CW002 in Healthy Adult Anesthetized Volunteers

Details for clinical trial NCT01338935

Clinical trial NCT01338935 - References