NCT01623271 - 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)

Mao J, Chen LL
Systemic lidocaine for neuropathic pain relief. Pain. 2000 Jul;87(1):7-17. Review.
Mao J, Gold MS, Backonja MM
Combination drug therapy for chronic pain: a call for more clinical studies. J Pain. 2011 Feb;12(2):157-66. doi: 10.1016/j.jpain.2010.07.006. Epub 2010 Sep 17. Review.
Mao J
Translational pain research: achievements and challenges. J Pain. 2009 Oct;10(10):1001-11. doi: 10.1016/j.jpain.2009.06.002. Epub 2009 Jul 22. Review.
Sindrup SH, Jensen TS
Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. Review.
van de Vusse AC, Stomp-van den Berg SG, Kessels AH, Weber WE
Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1 [ISRCTN84121379]. BMC Neurol. 2004 Sep 29;4:13.

Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)

Clinical trial NCT01623271 - References