ENROLLING STUDIES July 2015
Interstitial Cystitis with Hunner’s Lesion
Allergan: A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS 400 mg in Females with Interstitial Cystitis with Hunner’s Lesion
- A diagnosis of IC with HL defined as: An unpleasant sensation(pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms(LUTS) of more than 6 months duration in the absence of infection or other identifiable causes(AUA guidelines), documented history or patient reported And
- Documented history of an observation of HL via cystoscopic procedure in which a lesion is defined as a circumscript, reddened mucosal area that can be small vessel radiating towards a central scar, and/or a fibrin deposit of coagulum attached to this area. Lesion may also be linear, fissure-like, and may be bleeding.
- Mean of the daily average pain score is between 4 and 9.5
- Daily average micturition frequency of 8 episodes
Interstitial Cystitis/ Bladder Pain Syndrome
Allergan: A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS 400 mg in Females with Interstitial Cystitis/Bladder Pain Syndrome
- A diagnosis of IC/BPS defined as: An unpleasant sensation(pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms(LUTS) of more than 6 months duration in the absence of infection or other identifiable causes(AUA guidelines), documented history or patient reported
- Mean of the daily average pain score is between 5 and 9.5
- Daily average micturition frequency of 8 episodes
Prostate Cancer
Astellas: A Prospective Observational Cohort Study of Patients with Castration Resistant Prostate Cancer (CPRC) in the United States
- Confirmed diagnosis of CRPC (defined by a minimum of two rising PSA levels to be measured at least 7 days apart and serum testosterone level <50ng/dl or with new evidence of metastatic disease by investigating physician)
- Initiating the first active course of anti-cancer treatment for M0 CRPC or for M1 CRPC (regardless of prior M0 CRPC treatment) such as anti-androgens, androgen synthesis inhibitors, chemotherapy, and immunotherapy or radionuclide therapy. Patients may be enrolled within 45 days from the time of treatment initiation
This is an Observational study and the Primary objectives of the study are to describe patterns of care, disease assessment methods, treatment decisions, physician referral and CRPC patient characteristics associated with these.
Aragon Pharmaceuticals, Inc.: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
- Androgen receptor antagonist
- Patient: Adenocarcinoma of the Prostate with high risk for metastasis, PSADT< 10 months, calculated at least 3 PSA values obtained during continuous ADT.
- Castration –resistant prostate cancer demonstrated during continuous ADT, 3 PSA rises at least 1 week apart with last PSA>2 ng/ml
- Surgically or medically castrated with testosterone levels of <50 ng/dl. If medically castrated, continuous dosing with GnRHa should be maintained.
- ECOG Performance Status grade 0 or 1
Orion Pharma: A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
- IP: Non-steroidal AR inhibitor
- Patient: Adenocarcinoma of the Prostate with high risk for metastasis, PSADT< 10 months, calculated at least 3 PSA values obtained during continuous ADT.
- Progressive castration –resistant prostate cancer demonstrated during continuous ADT, 3 PSA rises at least 1 week apart with last PSA>2 ng/ml, resulting 2 >50% increase over nadir.
- Surgically or medically castrated with testosterone levels of <50 ng/dl. If medically castrated, continuous dosing with GnRHa and should be maintained.
- ECOG Performance Status grade 0 or 1
