Urinary Bladder, OveractivePhase 2NCT01157377

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

A Phase 2 study testing AGN-214868 in people with Urinary Bladder, Overactive, run by Allergan at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Urinary Bladder, Overactive
What is being tested?: AGN-214868
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 3 sitesin 3 countries
Study dates: Oct 2010to May 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

United States1 site

Study site
Richmond, Virginia

Other trials in United States

France1 site

Study site
Lyon

Other trials in France

Netherlands1 site

Study site
Amsterdam

Other trials in Netherlands

About this study

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

Conditions: Urinary Bladder, Overactive
Being tested: AGN-214868, AGN-214868 placebo
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGN-214868Drug
AGN-214868 injected into the bladder.
AGN-214868 placeboDrug
AGN-214868 placebo injected into the bladder.

Study groups in NCT01157377
Study group	Role	What they receive
AGN-214868 total dose 500 ng	Experimental	AGN-214868 injected into the bladder for total dose of 500 ng on Day 1. Receives: Drug: AGN-214868
AGN-214868 total dose 1000 ng	Experimental	AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1. Receives: Drug: AGN-214868
AGN-214868 total dose 2000 ng	Experimental	AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1. Receives: Drug: AGN-214868
AGN-214868 total dose 6000 ng	Experimental	AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1. Receives: Drug: AGN-214868
AGN-214868 total dose 18000 ng	Experimental	AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1. Receives: Drug: AGN-214868
AGN-214868 total dose 60000 ng	Experimental	AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1. Receives: Drug: AGN-214868
Placebo to AGN-214868	Placebo comparator	Placebo to AGN-214868 injected into the bladder on Day 1. Receives: Drug: AGN-214868 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010May 2013

First posted7 Jul 2010 (estimated)
Study startOct 2010
Primary completionFeb 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01157377
Sponsor's protocol ID: 214868-004
Status last verified: Feb 2014
First submitted: 1 Jul 2010
Last updated: 19 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
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Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

All Urinary Bladder, Overactive trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
ClinicalTrials.gov ID: NCT01157377
Acronym / sponsor ID: 214868-004
Conditions: Urinary Bladder, Overactive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Feb 2013 (actual)
Study completion: May 2013 (actual)
First posted: 7 Jul 2010 (estimated)
Results: Posted 19 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
AGN-214868 total dose 500 ng	Experimental	Drug: AGN-214868AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
AGN-214868 total dose 1000 ng	Experimental	Drug: AGN-214868AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
AGN-214868 total dose 2000 ng	Experimental	Drug: AGN-214868AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
AGN-214868 total dose 6000 ng	Experimental	Drug: AGN-214868AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
AGN-214868 total dose 18000 ng	Experimental	Drug: AGN-214868AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
AGN-214868 total dose 60000 ng	Experimental	Drug: AGN-214868AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
Placebo to AGN-214868	Placebo comparator	Drug: AGN-214868 placeboPlacebo to AGN-214868 injected into the bladder on Day 1.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AGN-214868AGN-214868 injected into the bladder.	Drug	AGN-214868 total dose 1000 ng, AGN-214868 total dose 18000 ng, AGN-214868 total dose 2000 ng, AGN-214868 total dose 500 ng, AGN-214868 total dose 6000 ng, AGN-214868 total dose 60000 ng
AGN-214868 placeboAGN-214868 placebo injected into the bladder.	Drug	Placebo to AGN-214868

Primary outcome

Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
Time frame: 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).

Results and safety

Results posted to the registry on 19 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AGN-214868 Total Dose 500 ng	23	21
AGN-214868 Total Dose 1000 ng	23	20
AGN-214868 Total Dose 2000 ng	27	26
AGN-214868 Total Dose 6000 ng	15	14
AGN-214868 Total Dose 18000 ng	20	18
AGN-214868 Total Dose 60000 ng	19	16
Placebo to AGN-214868	29	27

Primary outcome: Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: Episodes

Measure	AGN-214868 Total Dose 500 ng n = 22	AGN-214868 Total Dose 1000 ng n = 23	AGN-214868 Total Dose 2000 ng n = 27	AGN-214868 Total Dose 6000 ng n = 15	AGN-214868 Total Dose 18000 ng n = 19	AGN-214868 Total Dose 60000 ng n = 19	Placebo to AGN-214868 n = 29
Baseline	13.7 (4.98)	12.2 (4.08)	11.0 (3.44)	10.6 (2.27)	11.7 (3.90)	11.6 (3.23)	11.0 (2.48)
Change from Baseline at Week 12	-2.6 (6.38)	-2.1 (2.45)	-1.3 (4.26)	-0.9 (2.40)	-1.7 (3.90)	-2.7 (2.62)	-1.9 (2.18)

Population analysed: Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AGN-214868 Total Dose 500 ng	2 of 23 (8.7%)	23 of 23 (100%)	Not reported
AGN-214868 Total Dose 1000 ng	1 of 23 (4.3%)	22 of 23 (95.7%)	Not reported
AGN-214868 Total Dose 2000 ng	3 of 27 (11.1%)	27 of 27 (100%)	Not reported
AGN-214868 Total Dose 6000 ng	1 of 15 (6.7%)	15 of 15 (100%)	Not reported
AGN-214868 Total Dose 18000 ng	3 of 20 (15%)	20 of 20 (100%)	Not reported
AGN-214868 Total Dose 60000 ng	0 of 19 (0%)	19 of 19 (100%)	Not reported
Placebo to AGN-214868	1 of 29 (3.4%)	29 of 29 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Urinary Bladder, Overactive

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Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGN-214868 in people with Urinary Bladder, Overactive, run by Allergan at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01157377.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.