NCT00343356 - 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)

Calais da Silva F, Denis L, Bono A, Bollack C, Bouffioux C
Intravesical chemoresection with 4'-epi-doxorubicin in patients with superficial bladder tumors. Eur Urol. 1988;14(3):207-9.
Rintala E, Jauhiainen K, Rajala P, Ruutu M, Kaasinen E, Alfthan O
Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for carcinoma in situ of the bladder. The Finnbladder Group. J Urol. 1995 Dec;154(6):2050-3.

Clinical Study of Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder After Surgical Management

Clinical trial NCT00343356 - References