Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence

Allergan

Status and phase: Completed; Phase 2

Conditions: Urinary Bladder, Overactive

Treatments: Drug: AGN-214868; Drug: AGN-214868 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01157377

214868-004

Details and patient eligibility

About

This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• If female, must be of nonreproductive potential
• If male, must agree to use acceptable contraception
• Symptoms of overactive bladder with urinary urgency incontinence
• Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion criteria

• Overactive bladder caused by neurological condition (eg, spinal cord injury, multiple sclerosis)
• History of bladder surgery
• Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks
• Previous treatment with botulinum toxin therapy of any serotype for any urological condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 7 patient groups, including a placebo group

AGN-214868 total dose 500 ng

Experimental group

Description:

AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.

Treatment:

Drug: AGN-214868

AGN-214868 total dose 1000 ng

Experimental group

Description:

AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.

Treatment:

Drug: AGN-214868

AGN-214868 total dose 2000 ng

Experimental group

Description:

AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.

Treatment:

Drug: AGN-214868

AGN-214868 total dose 6000 ng

Experimental group

Description:

AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.

Treatment:

Drug: AGN-214868

AGN-214868 total dose 18000 ng

Experimental group

Description:

AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.

Treatment:

Drug: AGN-214868

AGN-214868 total dose 60000 ng

Experimental group

Description:

AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.

Treatment:

Drug: AGN-214868

Placebo to AGN-214868

Placebo Comparator group

Description:

Placebo to AGN-214868 injected into the bladder on Day 1.

Treatment:

Drug: AGN-214868 placebo