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

Phase 2

Completed

Conditions: Nocturia

Interventions: Other: Placebo
Drug: Paxerol - Dose Level 1
Drug: Paxerol - Dose Level 2
Drug: Paxerol - Dose Level 3

Registration Number: NCT02646826

Lead Sponsor: Wellesley Pharmaceuticals, LLC

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 Description: 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 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.

Study duration for each subject is approximately 4 weeks, which includes screening, baseline assessment, two weeks of treatment with study drugs, and follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects are treated with placebo tablets.
Paxerol - Dose Level 1	Paxerol - Dose Level 1	Subjects are treated with the first dose level of Paxerol.
Paxerol - Dose Level 2	Paxerol - Dose Level 2	Subjects are treated with the second dose level of Paxerol.
Paxerol - Dose Level 3	Paxerol - Dose Level 3	Subjects are treated with the third dose level of Paxerol.

Primary Outcome Measures

Name	Time	Method
Change in Nocturia Episodes	Up to 2 weeks	Change in 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).	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. This is on a scale of 0 to 100, with 0 being the best score.

Secondary Outcome Measures

Name	Time	Method
Duration of First Undisturbed Sleep (DFUS)	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	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

Trial Locations

Locations (4): The Westchester Medical Group PC
🇺🇸
Harrison, New York, United States
Washington High Urology
🇺🇸
New York, New York, United States
Dr. George Klein
🇺🇸
New York, New York, United States
A and I Medical P.C.
🇺🇸
Brooklyn, New York, United States