Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

NCT00284518 | Completed Phase 2 Results DMC

• 1 other identifier: 191622-517
• Study Type: interventional
• Target: 380
• Locations: 10 countries
• Sites: 10

Brief Summary

The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12

  The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.

  Baseline, Week 12

Secondary Outcomes (5)

• Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72

  Baseline, Week 72

• Change From Baseline in Peak Urine Flow Rate

  Baseline, Week 12, Week 72

• Change From Baseline in Total Prostate Volume

  Baseline, Week 12, Week 72

• Change From Baseline in Transitional Zone Prostate Volume

  Baseline, Week 12, Week 72

• Change From Baseline in Post-Void Residual

  Baseline, Week 2, Week 12, Week 72

Other Outcomes (1)

• Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain

  Baseline, Week 12, Week 72

Study Arms (4)

botulinum toxin Type A 300 U

EXPERIMENTAL

Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.

Biological: botulinum toxin Type A

botulinum toxin Type A 200 U

EXPERIMENTAL

Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.

Biological: botulinum toxin Type A

botulinum toxin Type A 100 U

EXPERIMENTAL

Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.

Biological: botulinum toxin Type A

Placebo (Normal Saline)

PLACEBO COMPARATOR

Placebo (Normal Saline) transperineal or transrectal injection on Day 1.

Drug: normal saline

Interventions

botulinum toxin Type A BIOLOGICAL

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

Also known as: BOTOX®

botulinum toxin Type A 100 U; botulinum toxin Type A 200 U; botulinum toxin Type A 300 U

normal saline DRUG

Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Placebo (Normal Saline)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower urinary tract symptoms due to benign prostatic hyperplasia
• Enlarged prostate volume by rectal ultrasound

You may not qualify if:

• Previous prostate surgery
• Previous or current diagnosis of prostate cancer
• Use of other medications for the treatment of prostatic hyperplasia
• Urinary tract infection

Sponsors & Collaborators

• Allergan: lead

Study Sites (11)

Unknown Facility

Murdoch, Australia

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Olomouc, Czechia

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Braunschweig, Germany

Location

Unknown Facility

Perugia, Italy

Location

Unknown Facility

Martin, Slovakia

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

• Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.

  PMID: 23098762 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 1, 2006
• Study Start: December 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: December 17, 2012
• Results First Posted: December 17, 2012

Record last verified: 2012-11

Locations

AU (1); GB (1); FR (1); CZ (1); CA (1); DE (1); IT (1); KR (1); TW (1); SL (1)