7 results
The primary objective of this study is to evaluate the efficacy of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC.The secondary objective is to evaluate the safety of EN3348 as compared with…
The purpose of the study is to assess the safety and efficacy of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.
Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…
Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…
-To investigate the feasibility, applicability, safety, tolerability, and reproducibility of addition of the capsaicin-heat model and the thermal grill to the existing nociceptive pain test battery in healthy subjects.-To investigate the feasibility…
To investigate wether neo-adjuvant chemotherapy followed by cytoreductive syurgery and hyperthermic chemotherapy is feasible and reduces the number of irresectable patients with acceptable morbidity and mortality rates.
Primary objective:To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in the 24-hr average pain intensity in subjects with PSNP.Secondary objective:• To demonstrate superiority of Qutenza over low…