Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004054

Trial Description

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Title

A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to assess the long-term safety and effectiveness of botulinum
toxin type A on patients with overactive bladder as a result of spinal cord injury or
multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376
and NCT00461292).

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Brief Summary in Scientific Language

Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the
arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving
forward. Also, the masking of the study is now open-label.

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Organizational Data

  •   DRKS00004054
  •   2012/07/31
  •   2009/04/01
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00876447  (ClinicalTrials.gov)
  •   191622-094  (Allergan)
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Health Condition or Problem studied

  •   Overactive Bladder
  •   N32.8 -  Other specified disorders of bladder
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Interventions/Observational Groups

  •   Biological: Botulinum Toxin Type A 300U
  •   Biological: Botulinum Toxin Type A 200U
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   [---]*
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes; time frame: Study Baseline, Week 6 Treatment Cycle 1; Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes; time frame: Study Baseline, Week 6 Treatment Cycle 2; Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes; time frame: Study Baseline, Week 6 Treatment Cycle 3; Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes; time frame: Study Baseline, Week 6 Treatment Cycle 4; Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
- Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes; time frame: Study Baseline, Week 6 Treatment Cycle 5; Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

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Secondary Outcome

- Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score; time frame: Study Baseline, Week 6 Treatment Cycle 1; The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
- Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score; time frame: Study Baseline, Week 6 Treatment Cycle 2; The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
- Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score; time frame: Study Baseline, Week 6 Treatment Cycle 3; The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
- Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score; time frame: Study Baseline, Week 6 Treatment Cycle 4; The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
- Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score; time frame: Study Baseline, Week 6 Treatment Cycle 5; The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
- Change From Study Baseline in Volume Per Void; time frame: Study Baseline, Week 6 Treatment Cycle 1; The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
- Change From Study Baseline in Volume Per Void; time frame: Study Baseline, Week 6 Treatment Cycle 2; The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
- Change From Study Baseline in Volume Per Void; time frame: Study Baseline, Week 6 Treatment Cycle 3; The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
- Change From Study Baseline in Volume Per Void; time frame: Study Baseline, Week 6 Treatment Cycle 4; The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
- Change From Study Baseline in Volume Per Void; time frame: Study Baseline, Week 6 Treatment Cycle 5; The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   New Zealand
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Singapore
  •   Slovakia
  •   South Africa
  •   Spain
  •   Taiwan, Province of China
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2009/01/31
  •   397
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patient has participated in study 191622-515 or 191622-516 and the following criteria
fulfilled:

- Patient completed at least 52 weeks in the preceding study.

- No longer than 6 months has elapsed since completion of the preceding study

- Patient has not received any prohibited medications during any intervening
period between the preceding study and this long-term study.

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Exclusion Criteria

- History or evidence of pelvic or urologic abnormality.

- Previous or current diagnosis of bladder or prostate cancer.

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Addresses

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    • Allergan
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Allergan
    • Medical Director 
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    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Allergan
    • Medical Director 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/09/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.