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Nocturia clinical trials

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NCT ID: NCT03116191 Completed - Clinical trials for Nocturia Due to Nocturnal Polyuria

Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Start date: February 23, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.

NCT ID: NCT03051009 Completed - Nocturia Clinical Trials

Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Start date: January 11, 2017
Phase: Phase 3
Study type: Interventional

Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year

NCT ID: NCT03048734 Completed - Hypertension Clinical Trials

Nocturnal Hypertension and Nocturia in African American Men

Start date: January 2017
Phase:
Study type: Observational

This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is independent determinantal of nocturia in African American men. We now went to pursue this correlation by designing a new NIH grant Proposal to determine whether replacing short acting with long acting drugs and dosing them at bed time rather than in the morning will: A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to nocturia in some patients.

NCT ID: NCT02905682 Completed - Nocturia Clinical Trials

Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects

Start date: September 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

NCT ID: NCT02904759 Completed - Nocturia Clinical Trials

Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

Start date: September 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.

NCT ID: NCT02878096 Completed - Nocturia Clinical Trials

Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study

Start date: July 2016
Phase: Phase 1
Study type: Interventional

The primary objectives of the study are: - To determine the absolute bioavailability of SK-1404 - To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404 - To provide plasma, urine and faecal samples for metabolite profiling and structural identification The secondary objectives of the study are: - To determine the routes and rates of elimination of [14C]-SK-1404 - To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity - To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404 - To further explore the PO PK of SK-1404 - To provide additional safety and tolerability information for SK-1404

NCT ID: NCT02835846 Completed - Overactive Bladder Clinical Trials

Investigation of the Effect of the Female Urinary Microbiome on Incontinence

FUM
Start date: September 2016
Phase: Phase 4
Study type: Interventional

This purpose of this study is to understand the types of bacteria that are in the bladder and vagina in patients with overactive bladder (OAB) symptoms and understand if the types of bacteria change when with the use of estrogen in the vagina. The investigators are also trying to understand how estrogen influences the body's ability to make substances called peptides that can kill bacteria.

NCT ID: NCT02646826 Completed - Nocturia Clinical Trials

Paxerolâ„¢ for Treatment of Nocturia - A Phase II Placebo-Controlled Trial

Start date: January 2016
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT02637960 Completed - Nocturia Clinical Trials

Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)

EQUINOC
Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

NCT ID: NCT02440841 Completed - Nocturia Clinical Trials

Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon

Start date: May 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.