The efficacy and safety of Nocturol are currently being studied in a Phase 2 double-blinded clinical trial underway in New York City and Long Island, NY. The underlying science appears rock solid so the logic of its efficacy should be obvious, but until the clinical trial results are available nothing is certain.
84 patients are being divided into 4 groups, with 21 taking 3 placebo pills, 21 taking 3 Nocturol pills, 21 taking 1 placebo and 2 Nocturol pills, and 21 taking 2 placebos and 1 Nocturol pill. After completing an initial physical, the qualified patients keep a Nocturia diary for 2 weeks to establish a baseline of their Nocturia frequency. Upon returning to the clinic, patients fill out a Nocturia quality of life survey to establish a baseline reflecting their happiness during the prior 2 weeks. They return their diaries and are then given new diaries and a 2-week supply of pills. The pills are to be taken 30 minutes before bedtime to allow the drug to begin its work before the bladder is emptied one last time before getting into bed. Upon completing the second 2-week period, the quality of life survey is once again completed and the diaries are collected.
As with any clinical trial, monitoring drug safety is a high priority, but based on the safety of the underlying drugs when taken in low doses, we expect no safety issues. The other major purpose of the trial is to evaluate the efficacy of various doses of Nocturol in reducing middle of the night bathroom visits.
A prior study using mouse and human bladder cells conducted at Ohio State University suggested that efficacy will not change with higher doses, but again scientific logic needs to be supported with clinical trial results to be certain about proper dosing.