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The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain from interstitial cystitis and/or painful bladder syndrome.
Interstitial cystitis (IC) and painful bladder syndrome (PBS) are urological disorders characterized by symptoms of bladder pain, urinary urgency, urinary frequency, and the need to get up during the night in order to urinate, thus interrupting sleep. These symptoms may negatively affect health-related quality of life and interfere with the patient's ability to work and function to their full capacity. This study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared with placebo in patients with moderate to severe, chronic bladder pain from IC/PBS.The study has 3 phases: a screening phase (up to 3 weeks), a double-blind treatment phase (12 weeks), and a post-treatment phase that ends 26 weeks after the last dose of study medication. During the post-treatment phase, efficacy evaluation will continue until Week 21 visit. The study duration will be approximately 36 to 46 weeks. Assessments of effectiveness include daily pain intensity scores and pain assessments as measured by standardized evaluation tools and patient questionnaires. Safety assessments include monitoring of adverse events, vital signs, physical examinations, neurologic examinations, clinical laboratory evaluations, electrocardiograms (ECGs), and injection site evaluations. Blood samples for pharmacokinetic (how the study medication is absorbed and distributed in the body, and how it is removed from the body over time) and immunogenicity (the ability of the study medication to start an immune response) evaluations will be collected, as well as a urine sample for biomarker (a substance used as an indicator of a biological state) evaluations. A single dose of JNJ-42160443 (9 milligrams in 0.9 milliliter) or matching placebo given as an injection under the skin once every 4 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Published on BioPortfolio: 2014-08-27T03:16:14-0400
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A condition with recurring discomfort or pain in the URINARY BLADDER and the surrounding pelvic region without an identifiable disease. Severity of pain in interstitial cystitis varies greatly and often is accompanied by increased urination frequency and urgency.
Inflammation of the URINARY BLADDER, either from bacterial or non-bacterial causes. Cystitis is usually associated with painful urination (dysuria), increased frequency, urgency, and suprapubic pain.
Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.
Inflammation of the interstitial tissue of the kidney. This term is generally used for primary inflammation of KIDNEY TUBULES and/or surrounding interstitium. For primary inflammation of glomerular interstitium, see GLOMERULONEPHRITIS. Infiltration of the inflammatory cells into the interstitial compartment results in EDEMA, increased spaces between the tubules, and tubular renal dysfunction.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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