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

NCT02646826 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2019-06-14

Study results available
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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.

Conditions

  • Nocturia

Interventions

OTHER

Placebo

Subjects are treated with Placebo tablets

DRUG

Paxerol - Dose Level 1

Subjects are treated with the first dose level of Paxerol

DRUG

Paxerol - Dose Level 2

Subjects are treated with the second dose level of Paxerol

DRUG

Paxerol - Dose Level 3

Subjects are treated with the third dose level of Paxerol

Sponsors & Collaborators

  • Wellesley Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • David A Dill · Wellesley Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-10-31
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02646826 on ClinicalTrials.gov