Clinical Trial: Paxerol™ for Treatment of Nocturia - A Phase II Placebo-Controlled Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Paxerol™ (a Novel Formulation of Acetaminophen and Ibuprofen) for Treatment of Nocturia - A Phase II Placebo-Controlled Trial

Brief Summary:

This is a multi-center, double-blind, placebo-controlled study with two weeks of daily oral administration of one of three dose levels of Paxerol or placebo in subjects with nocturia. Eligible study subjects will be identified according to inclusion/exclusion criteria (see below), and baseline assessments will be recorded.

Due to small sample size of 25 patients per group in this proof-of-principle dosing-finding trial, stratification according to gender and BMI will be difficult. However, similar distribution of patient types to the four treatment groups will be attempted by evenly assigning patients to the four treatment groups according to genders and body mass index (BMI) of <25, 25-30 and 30-40.

Paxerol or placebo will be taken 30 minutes before bedtime daily for two weeks. Nocturia frequency, Nocturia Quality of Life (NQOL), Duration of First Undisturbed Sleep (DFUS), total hours of nightly sleep, safety and tolerability will be monitored before and after a two-week treatment period. Results from subjects treated with different doses of Paxerol and placebo will be assessed and compared. Baseline urinary Prostaglandin E2 (PGE2) production will also be assayed to assess potential correlation between baseline urinary PGE2 production and responsiveness to Paxerol treatment.


Detailed Summary:

The co-primary objectives are:

A. To assess the effect of different doses of Paxerol on the reduction in the number of nocturia episodes.

B. To assess the clinical benefit of different doses of Paxerol in reducing nocturia via assessment of nocturia quality of life (NQOL).

The secondary objectives are to assess the effects of different doses of Paxerol on:

A. Duration of First Undisturbed Sleep (DFUS) B. Total hours of nightly sleep C. Safety and tolerability

An exploratory assessment is to evaluate baseline urinary PGE2 production on the responsiveness of subjects to Paxerol.

This is a multi-center, double-blind, placebo-controlled study with two weeks of daily oral administration of one of three dose levels of Paxerol or placebo in subjects with nocturia. Eligible study subjects will be identified according to inclusion/exclusion criteria (see below), and baseline assessments will be recorded.

Due to small sample size of 25 patients per group in this proof-of-principle dosing-finding trial, stratification according to gender and BMI will be difficult. However, similar distribution of patient types to the four treatment groups will be attempted by evenly assigning patients to the four treatment groups according to genders and body mass index (BMI) of <25, 25-30 and 30-40.

Paxerol or placebo will be taken 30 minutes before bedtime daily for two weeks. Nocturia frequency, Nocturia Quality of Life (NQOL), Duration of First Undisturbed Sleep (DFUS), total hours of nightly sleep, safety and tolerability will be monitored before a
Sponsor: Wellesley Pharmaceuticals, LLC

Current Primary Outcome:

  • Reduction in the number of nocturia episodes [ Time Frame: Up to 2 weeks ]
    The degree in the reduction in the number of nocturia episodes associated with one of three dose levels of Paxerol vs. placebo is assessed during the 2-week treatment period.
  • Clinical benefit based on nocturia quality of life (NQOL). [ Time Frame: Up to 2 weeks ]
    The degree of clinical benefit, via NQOL, associated with one of three dose levels of Paxerol vs. placebo is assessed after the 2-week treatment period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of First Undisturbed Sleep (DFUS) [ Time Frame: Up to 2 weeks ]
    DFUS will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo
  • Total hours of nightly sleep [ Time Frame: Up to 2 weeks ]
    The total hours of nightly sleep will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo
  • Changes based on physical exam [ Time Frame: Up to 2 weeks ]
    Changes based on physical exam, including blood pressure, heart rate, body temperature and respiratory rate, that are treatment related
  • Abnormal clinical laboratory values [ Time Frame: Up to 2 weeks ]
    Abnormal clinical laboratory test values, including hematology, coagulation, and chemistry panels, that are are treatment related
  • Urinalysis. [ Time Frame: Up to 2 weeks ]
    Abnormal urinalysis values that are treatment related


Original Secondary Outcome: Same as current

Information By: Wellesley Pharmaceuticals, LLC

Dates:
Date Received: December 30, 2015
Date Started: January 2016
Date Completion: March 2017
Last Updated: November 22, 2016
Last Verified: November 2016