Paxerol™ for Treatment of Nocturia - A Phase II Placebo-Controlled Trial
Public ClinicalTrials.gov record NCT02646826. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Paxerol™ (a Novel Formulation of Acetaminophen and Ibuprofen) for Treatment of Nocturia - A Phase II Placebo-Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02646826
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Interventions
- Placebo Other
- Paxerol - Dose Level 1 Drug
- Paxerol - Dose Level 2 Drug
- Paxerol - Dose Level 3 Drug
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2015
- Primary completion
- Sep 30, 2017
- Completion
- Oct 31, 2017
- Last update posted
- Jun 13, 2019
2016 – 2017
United States locations
- U.S. sites
- 4
- U.S. states
- 1
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| A and I Medical P.C. | Brooklyn | New York | 11229 | — |
| The Westchester Medical Group PC | Harrison | New York | 10604 | — |
| Dr. George Klein | New York | New York | 10021 | — |
| Washington High Urology | New York | New York | 10032 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02646826, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 13, 2019 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02646826 live on ClinicalTrials.gov.