We often have multiple clinical trials running. Please feel free to review the following ongoing studies accepting enrollment to see if you are a candidate to participate. You may also contact our Research Coordinator, Haleema, by calling 732-494-9400, ext 1224, for more information.
Prostate Cancer Studies
A Prospective Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (CRPC) in the United States
*Male patient 18 years or older
*Patient may have M0 or M1 disease
*Confirmed diagnosis of CRPC
*Clear progressive disease, as evidenced by a minimum of two rising PSA
*Estimated life expectancy of ≥ 6 months
*Initiating the first or second line treatment for CRPC
A Multinational, Randomized Placebo-Controlled, Phase III Efficacy and Safety Study Of ODM-201 in Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer
*Male patient 18 years or older
*Histologically or cytologically confirmed adenocarcinoma of prostate without neuro-endocrine differentiation or small cell features.
*CRPC defined as 3 rising PSA
*Castrate level of serum testosterone <1.7 nmol/l
*Patients excluded if prior treatment with second generation AR inhibitors or other investigational AR inhibitors.
*Patients excluded if prior chemotherapy or immunotherapy for prostate cancer.
Neurogenic Bladder Study
A Phase 3, Placebo controlled study to assess the efficacy and safety of one or more intradetrusor treatments of 600 or 800 units of DYSPORT® for the treatment of urinary incontinence in subjects with neurogenic detrusor inactivity due to spinal cord injury or multiple sclerosis.
*Males or Females aged 18 to 80 years inclusive.
*Urinary incontinence (UI) for at least 3 months prior to screening as a result of Neurogenic Detrusor Overactivity (NDO) due to spinal cord injury or Multiple sclerosis.
*Routinely performing Clean Intermittent Catheterization (CIC) every 4-6 hrs and CIC must be stable for at least 4 weeks prior to screening.
*Average of at least two episodes per day of UI recorded on the screening bladder diary.
*Excluded if any current condition other than NDO that may impact the bladder function.
*Excluded if Botox treatment within 9 mo. Prior to screening for any urological condition, and Botox 3 mo. prior to screening for non-urological condition.
*Excluded if Bladder instillation 3 mo. Prior to screening.
Over Active Bladder Studies
A Phase 4 study to evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
*Men aged 40 or more
*Symptom of OAB at least 3 months or more prior to screening.
*PSA < 4 ng/ml
*Experiences an average of 2 episodes (grade 3 or 4) of urgency per day.
*Patients excluded if neurogenic bladder or diabetic neuropathy.
*Patients excluded if received intravesical injections in the past 12 months with Botox.
*Patients excluded if uncontrolled hypertension.
A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients with Urinary Incontinence
*Male or female 18 years or over.
*Symptoms of OAB with urinary incontinence for over a period of at least 6 months prior to screening.
*Excluded if symptoms of OAB due to any Neurological reasons.
*Excluded if treated with any intravesical agent within 12 months.
*Excluded if previously treated with Botox for any urological condition.
Interstital Cystitis/Bladder Pain Syndrome Study
A 12-Week, Randomized, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of 2 Doses of AQX-1125 Targeting the SHIP1 Pathway in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Followed by a 40-Week Extension Period
*Males and females at least 18 – 80 years of age at screening.
*Consistently had symptoms of bladder pain in addition to urinary urgency/frequency for more than 6 months.
*Clinical diagnosis of IC/BPS for more than 3 months, but less than 20 years.
For inquiries on our clinical research trials, please call our office or email the clinical research staff.
Address: 10 Parsonage Road
Edison, NJ 08837
Phone: 732-494-9400 ext 1224
Email: [email protected]