NCT01050114 - 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)

Liu HT, Tyagi P, Chancellor MB, Kuo HC
Urinary nerve growth factor but not prostaglandin E2 increases in patients with interstitial cystitis/bladder pain syndrome and detrusor overactivity. BJU Int. 2010 Dec;106(11):1681-5. doi: 10.1111/j.1464-410X.2009.08851.x.
O'Leary M, Erickson JR, Smith CP, McDermott C, Horton J, Chancellor MB
Effect of controlled-release oxybutynin on neurogenic bladder function in spinal cord injury. J Spinal Cord Med. 2003 Summer;26(2):159-62.
Smith CP, Chancellor MB
Emerging role of botulinum toxin in the management of voiding dysfunction. J Urol. 2004 Jun;171(6 Pt 1):2128-37. Review.
Smith CP, Nishiguchi J, O'Leary M, Yoshimura N, Chancellor MB
Single-institution experience in 110 patients with botulinum toxin A injection into bladder or urethra. Urology. 2005 Jan;65(1):37-41.
Tyagi P, Barclay D, Zamora R, Yoshimura N, Peters K, Vodovotz Y, Chancellor M
Urine cytokines suggest an inflammatory response in the overactive bladder: a pilot study. Int Urol Nephrol. 2010 Sep;42(3):629-35. doi: 10.1007/s11255-009-9647-5. Epub 2009 Sep 26.

A Double-Blind, Randomized Study of the Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT-A) Versus Oral Oxybutynin in Spinal Cord Injured Patients With Neurogenic Detrusor Overactivity (Protocol Number 11-09-10-04)

Details for clinical trial NCT01050114

Clinical trial NCT01050114 - References