NCT00355277 - 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)

Dualé C, Daveau J, Cardot JM, Boyer-Grand A, Schoeffler P, Dubray C
Cutaneous amitriptyline in human volunteers: differential effects on the components of sensory information. Anesthesiology. 2008 Apr;108(4):714-21. doi: 10.1097/ALN.0b013e3181672632.
Kissin I, McDanal J, Xavier AV
Topical lidocaine for relief of superficial pain in postherpetic neuralgia. Neurology. 1989 Aug;39(8):1132-3.
McQuay HJ, Tramèr M, Nye BA, Carroll D, Wiffen PJ, Moore RA
A systematic review of antidepressants in neuropathic pain. Pain. 1996 Dec;68(2-3):217-27.
Sawynok J, Esser MJ, Reid AR
Antidepressants as analgesics: an overview of central and peripheral mechanisms of action. J Psychiatry Neurosci. 2001 Jan;26(1):21-9. Review.

Local Anaesthetic Effects of Transcutaneous Amitriptyline in Human Volunteers : a Controlled, Double-blinded, Randomised Study Versus Placebo and Transcutaneous Local Anaesthetic (EMLA(R))

Details for clinical trial NCT00355277

Clinical trial NCT00355277 - References