Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder

Inclusion Criteria

• Aged >=20 years at the time of signing the informed consent.
• Subject has symptoms of OAB (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening, determined by documented subject history.
• Subject has not been adequately managed with one or more medications (that is, anticholinergics or beta-3 adrenergic receptor agonist) for treatment of their OAB symptom. 'Not adequately managed' is defined as: An inadequate response after at least a 4-week period of OAB medication(s) on an approved optimized dose(s), that is, subject is still incontinent despite medication(s) for OAB; or limiting side effects (that is, condition that subject reduced dosage or discontinued the medication due to side effect after at least a 2-week period of OAB medication(s) on an approved optimized dose(s)).
• Subject who experiences all of the following, in the 3-day subject bladder diary completed during the screening phase:
• >= 3 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day
• urinary frequency (defined as an average of >= 8 micturitions [toilet voids] per day, that is, a total of >= 24 micturitions)
• Subject is willing to use clean intermittent catheterization (CIC) to drain urine if it is determined to be necessary by the investigator (or subinvestigator).
• Body weight >=40 kilograms (kg) at screening.
• Males or females:
• Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until the study exit:
• Vasectomy with documentation of azoospermia.
• Male condom plus partner use of one of the contraceptive options below: Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness criteria including a 10 nanograms (ng)/mL at Screening. Subjects with a PSA level of >= 4 ng/mL but 2 times the upper limit of normal (ULN) at screening.
• Alanine aminotransferase (ALT) > 2xULN; and bilirubin > 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block from the result of electrocardiogram (ECG) at screening. Notes:
• The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read
• The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial
• Subject has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis.
• Subject received anticholinergic, beta-3 adrenergic receptor agonist or any other medications or therapies to treat symptoms of OAB, including nocturia, within 7 days prior to the start of the screening phase.
• Subject has been treated with any intravesical pharmacologic agent (example, capsaicin, resiniferatoxin) for OAB symptoms within 12 months prior to initiation of Treatment phase 1 (Week 0).
• Subject has previous or current use of botulinum toxin therapy of any serotype for the treatment of any urological condition.
• Subject has previous use within 12 weeks prior to initiation of Treatment phase 1 (Week 0) or current use of botulinum toxin therapy of any serotype for any non-urological condition or beauty care.
• Subject has been immunized for botulinum toxin of any serotype.
• Subject cannot withhold any antiplatelet or anticoagulant therapy or medications with anticoagulative effects for 3 days prior to initiation of Treatment phase 1 (Week 0). Some medications may need to be withheld fo