This trial is looking at the safety and effectiveness of the experimental drug, called FE 201836, in treating nocturia. The main outcome to be measured in this study is the change in the number of nighttime urinations during the 12 week study period.
The details
Nocturia refers to waking up at night to urinate. The main symptom is urinating 2 or more times per night, on most nights. Sleep interruptions can severely affect a patient's quality of life. Nocturia is treated by lifestyle changes or addressing the underlying condition causing the nocturia. It can also be treated by the drug desmopressin (Noctiva, Minirin). Desmopressin mimics the action of the hormone vasopressin and can help to regulate urine production. FE 201836 is a new drug being developed for the treatment of nocturia.
This study is examining the safety and effectiveness of FE 201836 compared to desmopressin. The main outcome to be measured in this study is the change in the number of nighttime urinations during the 12 week study period.
Who are they looking for?
300 participants are needed for this study. Participants should have nocturia symptoms in the 6 months before visit 1 of the study.
Participants should not have a diagnosis of obstructive sleep apnoea, restless leg syndrome, bladder outlet blockage, urinary leakage, a neurological condition affecting urinary function or muscles, uncontrolled high blood pressure, uncontrolled diabetes mellitus or diabetes insipidus. Participants should not have had pelvic surgery, lower urinary tract surgery, pelvic radiation in the 6 months before visit 1. Participants should not have a history of genital or urinary illness which may cause urinary leakage. Participants should not drink more than 3L per day or have excessive thirst. Participants should not have a suspicion or evidence of heart failure. Participants should not have low sodium levels.
How will it work
Participants will be randomised to one of three groups. Group 1 will receive a placebo. Group 2 will receive FE 201836. Group 3 will receive desmopressin. They will receive the treatments for up to 12 weeks. After this, participants will again be randomly assigned to one of 8 groups (placebo, 6 different doses of FE 201836 and desmopressin). Quality of life and nocturia symptoms will be assessed by questionnaires during 12 weeks of treatment.
