Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder (SCORPIO)

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Mirabegron; Drug: Placebo to Tolterodine; Drug: Placebo to Mirabegron; Drug: Tolterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689104

178-CL-046

2007-001451-19 (EudraCT Number)

Details and patient eligibility

About

The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

Enrollment: 2,336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is willing and able to complete the micturition diary and questionnaires correctly
• Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
• Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
• Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period

Exclusion criteria

• Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
• Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
• Subject has an indwelling catheter or practices intermittent self-catheterization
• Subject has diabetic neuropathy
• Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
• Subject receives non-drug treatment including electro-stimulation therapy
• Subject has severe hypertension
• Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
• Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
• Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
• Subject has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) > 3x ULN
• Subject has a clinically significant abnormal electrocardiogram (ECG)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,336 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.

Treatment:

Drug: Placebo to Mirabegron

Drug: Placebo to Tolterodine

Mirabegron 50 mg

Experimental group

Description:

Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Treatment:

Drug: Placebo to Tolterodine

Drug: Mirabegron

Mirabegron 100 mg

Experimental group

Description:

Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.

Treatment:

Drug: Placebo to Tolterodine

Drug: Mirabegron

Tolterodine SR 4 mg

Active Comparator group

Description:

Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.

Treatment:

Drug: Tolterodine

Drug: Placebo to Mirabegron