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Trial record 5 of 20 for:    Peyronies disease

Peyronie's Disease Treatment Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hybrid Medical
ClinicalTrials.gov Identifier:
NCT02072018
First received: July 9, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose
Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the safety and efficacy of a new compound to treat this disease.

Condition Intervention Phase
Peyronie's Disease
Drug: H-100
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Sequential, Randomized, Double-blind, Placebo-controlled, Prospective Study to Evaluate the Safety and Efficacy of the H-100 Treatment in Adult Male Volunteers With Peyronie's Disease

Further study details as provided by Hybrid Medical:

Primary Outcome Measures:
  • Safety measure [ Time Frame: Up to six months ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events. Continuous monitoring for adverse events. An adverse event is the development of an undesirable medical condition - e.g. symptoms or abnormal results of an investigation - or the deterioration of a pre-existing medical condition (not relevant in this study). Per the subject description, adverse events will be reported as: mild, moderate or severe.


Secondary Outcome Measures:
  • Efficacy measure [ Time Frame: Up to three and six months (the Placebo group will change from Placebo to H-100 at the end of three months) ] [ Designated as safety issue: Yes ]

    Measure for change in pain, curvature, length, plaque hardness and plaque size. At the end of three months the Placebo group will change from Placebo to H-100 for the remaining three months. The H-100 group will receive H-100 for six months.

    Monitor for adverse events.



Enrollment: 22
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: H-100
H-100, gel, daily, 6 months
Drug: H-100
H-100 is a new compound to be applied to Peyronie's disease tissue with the intention of reducing disease symptoms.
Placebo Comparator: Placebo
Placebo gel, daily, three months then switch to H-100 for three months
Drug: H-100
H-100 is a new compound to be applied to Peyronie's disease tissue with the intention of reducing disease symptoms.
Drug: Placebo
Placebo is an established, standard compound to be applied to Peyronie's disease tissue that will have no effect on disease symptoms.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have symptom(s) of Peyronie's disease (pain, curvature or plaque)
  2. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
  3. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
  4. Be able to read, complete and understand the informed consent and various rating instruments in English

Exclusion Criteria:

  1. Inability to understand study goals and risks
  2. Inability to understand the informed consent
  3. Inability to achieve erection with or without PDE5 inhibitor use adequate for penetration if penile curvature is not a limiting factor
  4. Peyronie's disease symptoms greater than one year duration
  5. Chordee in the presence or absence of hypospadias Thrombosis of the dorsal penile artery or vein Infiltration by a benign or malignant mass resulting in penile curvature Infiltration by an infectious agent, such as lymphogranuloma venereum Ventral curvature from any cause Presence of an active sexually transmitted disease Known active hepatitis B or C Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
  6. Has previously undergone surgery for Peyronie's disease
  7. Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subject's penile deformity
  8. Has an isolated hourglass deformity of the penis (curvature caused by a plaque that is noncontiguous with the hourglass deformity may be treated)
  9. Has the plaque causing curvature of the penis located proximal to the base of the penis
  10. Has previously received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
  11. Has received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E [>500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
  12. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6- month period before screening or plans to have ESWT at any time during the study
  13. Has used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study
  14. Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study
  15. Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
  16. Has uncontrolled hypertension, as determined by the investigator
  17. Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
  18. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
  19. Has received an investigational drug or treatment within 30 days before the first dose of study drug
  20. Has a known systemic allergy to any H-100 component
  21. Has received any collagenase treatments within 30 days of the first dose of study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072018

Locations
United States, Minnesota
North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
Sponsors and Collaborators
Hybrid Medical
Investigators
Principal Investigator: Jeffry Twidwell, MD North Memorial Medical Center
  More Information

Responsible Party: Hybrid Medical
ClinicalTrials.gov Identifier: NCT02072018     History of Changes
Other Study ID Numbers: PDTP1 
Study First Received: July 9, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hybrid Medical:
Peyronie's
Peyronie's disease
Treatment
Clinical Study

Additional relevant MeSH terms:
Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases

ClinicalTrials.gov processed this record on December 02, 2016