Informal studies showed the direct impact of Nocturol on prostaglandin production in the bladder. Whereas due to normal Circadian rhythm activity, prostaglandin production in the bladder tends to naturally decline about 35% overnight, when using Nocturol the reductions ranged from 71% to 75%.
By collecting consistently gathered urine samples for a few nights, this result could easily be verified by scientists or healthcare professionals for a few hundred dollars with little fear of placebo effects. It is unlikely that any patients could imagine their way to lowering prostaglandin production, so the easily observable reductions can only be caused by the combined effects of acetaminophen and ibuprofen.
The results of the 86 patient placebo controlled trial were backed up by a P value of 0.0017, which is far better than the 0.05 target normally used, so there is little doubt about the results. The results by patient varied widely as expected because while some patients’ nocturia is only caused by excess prostaglandin production, most patients are also affected by polyuria or the timing of their choices of foods and drinks that contain caffeine or alcohol. Even the time that patients go to bed can affect nocturia, since there is a Circadian rhythm associated with prostaglandin production. Going to bed at 8pm is probably the worst plan and going to bed at midnight is probably the best plan if you want to minimize nocturia events, since prostaglandin product increases dramatically each evening until midnight.
In our clinical trial, 23% of the patients reported a 50-96% reduction in nightly bathroom visits, while 38% reported a 25-50% reduction. Placebo patients reported a 10% reduction, which is far different than the results in other nocturia clinical trials, which sometimes have 50% nocturia reductions for placebo patients. This dramatic difference is because we instructed patients before they started their baseline data recording regarding the fact that what they drink and when they drink it can have significant effects upon their nocturia results.
The other positive factor for our future trials is that results are likely to improve because: a) patients had 5% better results in their second week of using our drug, and b) patients drank 2-18 ounces of water with their 3 pills (only 1 pill will be used in future trials), and c) only 21% of the patients were women while 52% of nocturia patients are women and women had results 3 percentage points better than the men. We did not share our lifestyle instructions with patients, but our expectation is that many of them will experience much better results if they follow the instructions carefully.
By providing access to Nocturol and proper education, our future licensees will be able to give most patients the ability to enjoy a dramatic improvement in their quality of life and overall health.
An article describing our Phase 2 clinical trial results was published in Neurourology and Urodynamics, the journal of the International Continence Society. You may read it by clicking on this link: https://onlinelibrary.wiley.com/doi/10.1002/nau.23910. One of the authors of the article was Dr. Jeffrey Weiss, who is perhaps the world’s leading authority on nocturia. He was the first author listed on the book Nocturia, Causes, Consequences, and Clinical Approaches. Yet another source of information regarding our drug is the new book recently published by Dr. King Lee and Dr. Jeffrey Weiss titled: Nocturia – Etiology, Pathology, Risk Factors, Treatment, and Emerging Therapies.