Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

This study has been completed.

Study NCT00311376 Information provided by Allergan

First Received on April 4, 2006. Last Updated on September 9, 2011 History of Changes

Results First Received: September 9, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Overactive Bladder
Interventions:	Biological: botulinum toxin Type A (200U) Biological: botulinum toxin Type A (300U) Other: Normal Saline (Placebo); botulinum toxin Type A (200U) Other: Normal Saline (Placebo); botulinum toxin Type A (300U)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Botulinum Toxin Type A (300U)	botulinum toxin Type A (300U)
Botulinum Toxin Type A (200U)	botulinum toxin Type A (200U)
Placebo	Normal saline (placebo)

Participant Flow for 2 periods

Period 1: Treatment Cycle 1

	Botulinum Toxin Type A (300U)	Botulinum Toxin Type A (200U)	Placebo
STARTED	132	135	149
COMPLETED	105	118	132
NOT COMPLETED	27	17	17

Period 2: Treatment Cycle 2

	Botulinum Toxin Type A (300U)	Botulinum Toxin Type A (200U)	Placebo
STARTED	115 ^[1]	125 ^[2]	0 ^[3]
COMPLETED	106	112	0
NOT COMPLETED	9	13	0

[1]	69 from the 300U group + 46 from the Placebo group entered Cycle 2
[2]	74 from the 200U group + 51 from the Placebo group entered Cycle 2
[3]	Cycle 1 Placebo pts were randomized to receive 300U or 200U in Cycle 2

Baseline Characteristics

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Reporting Groups

	Description
Botulinum Toxin Type A (300U)	botulinum toxin Type A (300U)
Botulinum Toxin Type A (200U)	botulinum toxin Type A (200U)
Placebo	Normal saline (placebo)

Baseline Measures

	Botulinum Toxin Type A (300U)	Botulinum Toxin Type A (200U)	Placebo	Total
Number of Participants [units: participants]	132	135	149	416
Age, Customized [units: participants]
<40 years	40	48	45	133
Between 40 and 64 years	83	73	95	251
Between 65 and 74 years	9	14	9	32
>=75 years	0	0	0	0
Gender [units: participants]
Female	89	80	76	245
Male	43	55	73	171

Outcome Measures

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1. Primary:

Change From Baseline in Number of Weekly Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 6 ]

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2. Secondary:

Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ]

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3. Secondary:

Change From Baseline in Maximum Detrusor Pressure (MDP) [ Time Frame: Baseline, Week 6 ]

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4. Secondary:

Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire [ Time Frame: Baseline, Week 6 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Therapeutic area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00311376 History of Changes
Other Study ID Numbers:	191622-515
Study First Received:	April 4, 2006
Results First Received:	September 9, 2011
Last Updated:	September 9, 2011
Health Authority:	United States: Food and Drug Administration