Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
NCT ID: NCT01357356
Last Updated: 2020-10-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
750 participants
INTERVENTIONAL
2011-05-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
NCT01900704
Treatment of Patients With Nocturia
NCT00937859
Treatment of Patients With Nocturia (Non-PK Study)
NCT00937378
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
NCT01259128
Long Term Safety Assessment of SER120 in Patients With Nocturia
NCT00981682
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SER120 (750 ng/day)
SER120 (750 ng/day)
SER120 (750 ng/day)
SER120 (1000 ng/day)
SER120 (1000 ng/day)
SER120 (1000 ng/day)
SER120 (1000 ng/day)
SER120 (1500 ng/day)
SER120 (1500 ng/day)
SER120 (1500 ng/day)
Placebo
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SER120 (750 ng/day)
SER120 (1000 ng/day)
SER120 (1000 ng/day)
SER120 (1500 ng/day)
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Nocturia of 6 or more months duration averaging greater than 2 nocturic episode per night
Exclusion Criteria
* Diabetis Insipidus
* Renal Insufficiency
* Hepatic Insufficiency
* Incontinence
* Illness requiring systemic steroids
* Malignancy within the past 5 years
* Sleep Apnea
* Nephrotic Syndrome
* Unexplained Pelvic Mass
* Urinary Bladder Neurological dysfunction
* Urinary Bladder Surgery or Radiotherapy
* Pregnant or Breast Feeding
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Serenity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Serenity R&D
New City, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPC-SER120-DB3-201101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.