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H-22411: BOTOX® for Peyronie's Disease

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ClinicalTrials.gov Identifier: NCT00812838
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE December 18, 2008
First Posted Date  ICMJE December 22, 2008
Results First Submitted Date  ICMJE January 13, 2020
Results First Posted Date  ICMJE February 17, 2020
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE August 7, 2009
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
Average Percent Change of Penile Curvature in Degrees [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]
Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16 *Crossover subjects were added to Experimental Group for analysis* Negative value equates to a reduction in curvature Positive value equates to an increase in curvature
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2008)
Change in penile curvature [ Time Frame: End of treatment at 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
  • Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV) [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]
    Results of penile doppler ultrasound from baseline/screening visit to end of treatment at week 16 will be compared. peak systolic velocity (PSV) and end-diastolic velocity (EDV) are assessed here. Change is calculated as week 16 values - screening visit values Negative values are a decrease in velocity Positive values are an increase in velocity
  • Change in Penile Blood Flow for Diameter [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]
    Results of penile doppler ultrasound from the baseline/screening visit to end of treatment at week 16 will be compared. Diameter is assessed here. Change is calculated as week 16 values - screening visit values Negative values are a decrease in diameter Positive values are an increase in diameter
  • Change in Penile Plaque Size [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]
    Results of ultrasound at baseline/screening visit to end of treatment at week 16 will be compared. *Crossover subjects were added to Experimental Group for analysis* Change is calculated as week 16 values values minus screening visit values Increase in value equates to increased plaque size Decrease in value equates to decreased plaque size
  • Changes in International Index of Erectile Function Scores (IIEF) [ Time Frame: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16 ]
    Subject's average scores on IIEF at baseline/screening visit to end of treatment at week 16 are compared The subscale measures self-reported erectile function. Maximum score is 30, Minimum is 0. A score of 0 is the absolute best outcome. A score of 30 is the absolute worst outcome. Erectile Function score is a summation of questions 1,2,3,4, and 15. This study is assessing their erectile function and not the other subscales. The other subscale scores are :
    1. Orgasmic Function (Questions 9, 10); Maximum score = 10, Minimum score = 0
    2. Sexual Desire (Questions 11, 12); Maximum score = 10, Minimum score = 0
    3. Intercourse Satisfaction (Questions 6, 7, 8); Maximum score = 15, Minimum score = 0
    4. Overall Satisfaction (Question 13, 14): Maximum score = 10, Minimum score = 0
    Subscales are not combined to make a total composite score. *Crossover subjects were added to Experimental Group for analysis*
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2008)
  • Improvements in penile blood flow [ Time Frame: End of participation at 16 weeks ]
  • Reduction in penile plaque size as seen on ultrasound [ Time Frame: End of participation at 16 weeks ]
  • Changes in IIEF scores [ Time Frame: End of participation at 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE H-22411: BOTOX® for Peyronie's Disease
Official Title  ICMJE The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease
Brief Summary

Peyronie's disease is a condition in which a plaque, or hard lump, forms on the penis. It causes hardened tissue, pain, and an abnormal bending in the penis. These symptoms are more severe during an erection. Significant bending of the penis can result in pain, poor erections, and an inability to engage in sexual intercourse.

This disease affects about 3% of the male population. The average age of onset of this disease is 57 years old. The cause of the disease is unknown. However, many believe that it may be due to trauma to the penis (such as injury or extremely vigorous sexual activity).

Detailed Description

Treatments for this disease have been limited and often unsuccessful. The goal of treatment is to reduce pain and maintain sexual function. Oral medicines that prevent plaque formation and promote plaque breakdown have not been effective. Many patients with the disease will require injections of medicines directly into the plaque. These injections have been used for over 50 years in the treatment of major Peyronie's disease. The disease often resolves on its own without treatment. Surgery may be performed to remove hardened tissue in the penis. However, surgery is not done during the first 12 months of the disease.

There are 2 phases of the disease: the active phase and the inactive phase. The active phase usually occurs during the first 12 months of the disease. The stabilization of the plaque is known as the inactive phase. We are inviting men with stable disease to take part in this study which will test BOTOX® versus a placebo (a placebo contains no medicine).

This will be a randomized, placebo-controlled, cross-over, single-center trial. The placebo group has the option to cross over to the treatment arm (ARM 1) of the study at the end of their 16 weeks of placebo arm (ARM 2). Study drug is Botulinum toxin type A (BOTOX®). Subjects who meet the inclusion criteria for the study will be randomized to either the treatment or placebo arm.

  • Treatment: Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline, or
  • Placebo: Injection solution will consist of 10 cc preservative free normal saline.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peyronie's Disease
Intervention  ICMJE
  • Drug: 100 units of Botulinum Toxin Type A
    Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
    Other Name: BOTOX®
  • Other: Preservative free normal saline
    Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque
  • Drug: 100 units Botulinum Toxin A
    Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
    Other Name: Cross-over
Study Arms  ICMJE
  • Experimental: 100 units of Botulinum Toxin Type A
    Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
    Intervention: Drug: 100 units of Botulinum Toxin Type A
  • Placebo Comparator: Normal saline

    Injection solution will consist of 10 cc preservative free normal saline

    Subjects had the choice of crossing over to ARM 1 at the end of 16 weeks.

    Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16.

    Interventions:
    • Other: Preservative free normal saline
    • Drug: 100 units Botulinum Toxin A
Publications * Khera M, Boone TB, Smith CP. Botulinum toxin type A: a novel approach to the treatment of recurrent urethral strictures. J Urol. 2004 Aug;172(2):574-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2008)
20
Actual Study Completion Date  ICMJE January 15, 2019
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with stable Peyronie's plaques.
  • Males at least 18 years of age
  • Must give informed consent.

Exclusion Criteria:

  • Subjects in the active phase of Peyronie's disease.
  • Subjects with less than 1 year history of Peyronie's disease.
  • Subjects taking oral medications for Peyronie's disease which include Trental, Viagra, vitamin E, colchicines, L-arginine, and tamoxifen. There will be a 2 week wash-out period if patients are on these medications.
  • Subjects with more than 1 penile plaque will be excluded from the study.
  • Subjects with calcified plaques demonstrated by ultrasound will be excluded from the study.
  • Known allergy or sensitivity to any components of the study medication (botulinum toxin A), anesthetics, or any other product associated with the treatment and general study procedures.
  • Any medical condition or neuromuscular disorder that may put the patient at increased risk with exposure to botulinum toxin A (BTX-A), including myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
  • Patient taking aminoglycosides or any drug known to interfere with neuromuscular transmission.
  • Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis.
  • Patient must not be taking aspirin, non-steroidal anti-inflammatory drugs, or Coumadin for 7 or more days prior to Botox injection.
  • Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident within the past 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00812838
Other Study ID Numbers  ICMJE 11-07-40-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be published in aggregate.
Responsible Party Mohit Khera, Baylor College of Medicine
Study Sponsor  ICMJE Mohit Khera
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Mohit Khera, MD, MBA Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP