Clinical Trial: Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of 50 mg, 100 mg and 200 mg PP4001 Twice Daily for the Treatment of Burning During Uri

Brief Summary: PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection. After the screening, patients are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period. The primary endpoint is burning during urination.

Detailed Summary:
Sponsor: Pinnacle Pharmaceuticals, Inc.

Current Primary Outcome: To assess the efficacy of PP4001 for the relief of burning during urination as measured by the subject's self-reported score at the time of urination in women with uUTI in comparison to placebo. [ Time Frame: Assessed at each urination from the time of randomization to 48 hours post first dose. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in the physical exam evaluation at the End of Study visit [ Time Frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit. ]

    Body systems evaluated will include:

    • General appearance
    • Skin
    • HEENT (Head, Ears, Eyes, Nose, Throat)
    • Spine/Neck/Thyroid
    • Respiratory
    • Cardiovascular
    • Abdomen
    • Nervous System
    • Musculoskeletal
  • To assess the efficacy of PP4001 for the relief of pain as measured by the subject's self-reported score at the time of urination. [ Time Frame: Assessed at each urination from the time of randomization through 48 hours post first dose. ]
  • To assess the efficacy of PP4001 for reduction in urination frequency as measured by the subject's self-reported void diary. [ Time Frame: Assessed at each urination from the time of randomization through 48 hours post first dose. ]
  • To evaluate the duration of therapeutic response to PP4001 50 mg, 100 mg and 200 mg. [ Time Frame: Efficacy measures assessed in 2-hour windows after each dose. ]
  • To assess global assessment of uUTI symptom severity and change over time as measured by the subject-reported global assessment diaries. [ Time Frame: Assessed at each urination from the time of randomization through 48 hours post first dose. ]
  • Change from baseline in vital signs at the End of Study visit [ Time Frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days after the End of Study Visit. ]
    Vital sign measures will include systolic and diastolic blood pressure, pulse, respiratory rate, and temperature.
  • Change from baseline in ECG at the End of Study visit [ Time Frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit. ]
    ECG parameters to be reported in this study include heart rate, and interval parameters of RR, PR, QRS, QT, and QTc.
  • Change from baseline in laboratory evaluations at the End of Study visit [ Time Frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit. ]
    The following laboratory assessments will be performed: venous blood and urine samples for clinical laboratory testing, including hematology, serum chemistry, urinalysis, and urine culture.
  • Frequency, severity and relationship to study medication of treatment emergent adverse events [ Time Frame: From first dose through the End of Study Visit (48 - 100 hours post first dose) ]
    Frequency of treatment emergent AEs will be calculated for each body system, by preferred term, by treatment and by period for the number of subjects reporting the event for the safety population. The severity of the AEs and the relationship to study medication will be summarized for each body system and preferred term. Withdrawals due to AEs will be summarized for each body system and preferred term.


Original Secondary Outcome: Same as current

Information By: Pinnacle Pharmaceuticals, Inc.

Dates:
Date Received: July 26, 2011
Date Started: July 2011
Date Completion:
Last Updated: October 18, 2011
Last Verified: October 2011