Treatment of prurigo nodularis
A technology for nodular prurigo and prurigo, applied in the direction of organic active ingredients, medical preparations of non-active ingredients, medical preparations containing active ingredients, etc., can solve problems that have not been fully understood
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example 1
[0193] 30 mg, 60 mg or 180 mg extended release (ER) nalbuphine tablets were prepared as follows: nalbuphine hydrochloride, mannitol, xanthan gum, locust bean gum and calcium sulfate dihydrate were added to a high shear mixer and mixed at low speed Dry mix. The granulation solution (water for injection or purified water) was introduced into the mixer at low speed. The wet granulation is granulated at high speed and dried in a fluid bed processor. The dried granules are ground and sized using a conventional mill. The milled granulation was transferred to a diffusion (drum) mixer. Add hydroxypropyl cellulose and, where applicable, fumaric acid (180 mg formulation only) to the diffusion mixer and blend. Thereafter, magnesium stearate was added to the diffusion mixer and blended. The final blend was compressed using a rotary tablet press. Tablets may be coated with a non-functional Opadry white coating.
[0194] Table 1
[0195] 30mg extended release nalbuphine tablet
[01...
example 2
[0205] This clinical study was a double-blind placebo-controlled trial in which patients with prurigo nodularis were randomized in a 1:1:1 ratio to nalbuphine ER tablets up to a target dose of 90 mg twice daily (BID), nalbuphine hydrochloride ER tablet 180 mg BID or placebo tablet BID. Use non-sedating emergency antihistamines (non-first-generation H1 antihistamines [Simons FE. Advances in H1-antihistamines]. "New England Journal of Medicine (N Engl J Med)" .2004;351(21):2203-17.]) is permitted but documented in research. Cleansing emollients are permitted for hygiene purposes as long as the lotion does not contain active substances such as menthol or urea. The placebo comparator was chosen because there is no approved treatment for prurigo nodularis in the US or Europe or an established standard of care that could serve as an active control.
[0206] The primary objective was to use the Worst Itch Intensity Numeric Rating Scale (NRS, 0 [not itchy]-10 [worst possible itch]; ...
example 3
[0304] This clinical study is a Phase 2 open-label extension of the randomized, double-blind, 3-parallel group, placebo-controlled dose-ranging study described in Example 2 (Clinical Study TR03ext). All those subjects who were randomized and then completed the Example 2 study were eligible for participation in the extension study.
[0305] The primary endpoint was a description of the overall incidence and nature of treatment-emergent AEs (TEAEs) during Weeks 5-50 of the study. Exploratory efficacy endpoints include the worst Changes in Itchy NRS, Itchy VRS, and ItchyQoL from Baseline Patient Reported Outcome Measures by On-Treat Study Visit and Baseline NRS Scores. There is also an assessment of any underlying skin lesion changes over time using the PAS metric.
[0306] Number of patients (planning and analysis)
[0307] Of the 63 patients randomized to the study of Example 2, 36 subjects enrolled in the extension study entered the treatment phase of the study and were ...
PUM
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