NCT01385904 - 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)

Clements JA, Nimmo WS, Grant IS
Bioavailability, pharmacokinetics, and analgesic activity of ketamine in humans. J Pharm Sci. 1982 May;71(5):539-42.
Finch PM, Knudsen L, Drummond PD
Reduction of allodynia in patients with complex regional pain syndrome: A double-blind placebo-controlled trial of topical ketamine. Pain. 2009 Nov;146(1-2):18-25. doi: 10.1016/j.pain.2009.05.017. Epub 2009 Aug 22.
Grant IS, Nimmo WS, Clements JA
Pharmacokinetics and analgesic effects of i.m. and oral ketamine. Br J Anaesth. 1981 Aug;53(8):805-10.
Lynch ME, Clark AJ, Sawynok J, Sullivan MJ
Topical 2% amitriptyline and 1% ketamine in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005 Jul;103(1):140-6.
Pedersen JL, Galle TS, Kehlet H
Peripheral analgesic effects of ketamine in acute inflammatory pain. Anesthesiology. 1998 Jul;89(1):58-66.
Pöyhiä R, Vainio A
Topically administered ketamine reduces capsaicin-evoked mechanical hyperalgesia. Clin J Pain. 2006 Jan;22(1):32-6.
Zapantis G, Csóka I, Csányi E, Horváth G, Erös I
Evaluation of ketamine systemic absorption from topical preparations. Short Communication. Acta Biol Hung. 2006 Sep;57(3):387-9.

Plasma Concentrations of Ketamine and Norketamine in Patients Using Topical Application of 10% Ketamine for Neuropathic Pain.

Clinical trial NCT01385904 - References