Urinary Bladder, Overactive
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.
Interventions
DRUGAGN-214868
AGN-214868 injected into the bladder.
DRUGAGN-214868 placebo
AGN-214868 placebo injected into the bladder.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline, Week 12 | The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes). |
Countries
France, Netherlands, United States
Participant flow
Pre-assignment details
160 patients were enrolled, 3 patients did not receive treatment and 1 patient received an incorrect dose. 156 patients were included in the Safety Population.
Participants by arm
| Arm | Count |
|---|---|
| AGN-214868 Total Dose 500 ng AGN-214868 injected into the bladder for total dose of 500 ng on Day 1. | 23 |
| AGN-214868 Total Dose 1000 ng AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1. | 23 |
| AGN-214868 Total Dose 2000 ng AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1. | 27 |
| AGN-214868 Total Dose 6000 ng AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1. | 15 |
| AGN-214868 Total Dose 18000 ng AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1. | 20 |
| AGN-214868 Total Dose 60000 ng AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1. | 19 |
| Placebo to AGN-214868 Placebo to AGN-214868 injected into the bladder on Day 1. | 29 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Other Miscellaneous Reasons | 0 | 2 | 0 | 0 | 1 | 1 | 1 |
| Overall Study | Personal Reasons | 2 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | AGN-214868 Total Dose 500 ng | AGN-214868 Total Dose 1000 ng | AGN-214868 Total Dose 2000 ng | AGN-214868 Total Dose 6000 ng | AGN-214868 Total Dose 18000 ng | AGN-214868 Total Dose 60000 ng | Placebo to AGN-214868 |
|---|---|---|---|---|---|---|---|---|
| Age, Customized 40-64 years | 93 Participants | 16 Participants | 15 Participants | 14 Participants | 9 Participants | 13 Participants | 10 Participants | 16 Participants |
| Age, Customized < 40 years | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized >=65 years | 59 Participants | 6 Participants | 7 Participants | 12 Participants | 6 Participants | 7 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Female | 144 Participants | 23 Participants | 20 Participants | 23 Participants | 14 Participants | 19 Participants | 18 Participants | 27 Participants |
| Sex: Female, Male Male | 12 Participants | 0 Participants | 3 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 23 | 22 / 23 | 27 / 27 | 15 / 15 | 20 / 20 | 19 / 19 | 29 / 29 |
| serious Total, serious adverse events | 2 / 23 | 1 / 23 | 3 / 27 | 1 / 15 | 3 / 20 | 0 / 19 | 1 / 29 |
Outcome results
Primary
Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).
Time frame: Baseline, Week 12
Population: Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-214868 Total Dose 500 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Change from Baseline at Week 12 | -2.6 Episodes | Standard Deviation 6.38 |
| AGN-214868 Total Dose 500 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline | 13.7 Episodes | Standard Deviation 4.98 |
| AGN-214868 Total Dose 1000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline | 12.2 Episodes | Standard Deviation 4.08 |
| AGN-214868 Total Dose 1000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Change from Baseline at Week 12 | -2.1 Episodes | Standard Deviation 2.45 |
| AGN-214868 Total Dose 2000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline | 11.0 Episodes | Standard Deviation 3.44 |
| AGN-214868 Total Dose 2000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Change from Baseline at Week 12 | -1.3 Episodes | Standard Deviation 4.26 |
| AGN-214868 Total Dose 6000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Change from Baseline at Week 12 | -0.9 Episodes | Standard Deviation 2.4 |
| AGN-214868 Total Dose 6000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline | 10.6 Episodes | Standard Deviation 2.27 |
| AGN-214868 Total Dose 18000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline | 11.7 Episodes | Standard Deviation 3.9 |
| AGN-214868 Total Dose 18000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Change from Baseline at Week 12 | -1.7 Episodes | Standard Deviation 3.9 |
| AGN-214868 Total Dose 60000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline | 11.6 Episodes | Standard Deviation 3.23 |
| AGN-214868 Total Dose 60000 ng | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Change from Baseline at Week 12 | -2.7 Episodes | Standard Deviation 2.62 |
| Placebo to AGN-214868 | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Change from Baseline at Week 12 | -1.9 Episodes | Standard Deviation 2.18 |
| Placebo to AGN-214868 | Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes | Baseline | 11.0 Episodes | Standard Deviation 2.48 |