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A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

NCT03201419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2022-03-02

Study results available
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Summary

The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults

Conditions

  • Nocturia

Interventions

DRUG

FE 201836

Oral solution for daily intake

DRUG

Desmopressin

Desmopressin Orally Disintegrating Tablet (ODT)

DRUG

Placebo oral solution

Manufactured to mimic experimental drug

DRUG

Placebo ODT

Manufactured to mimic experimental drug

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-27
Primary Completion
2019-10-31
Completion
2019-10-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Poland

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 NCT03201419 on ClinicalTrials.gov