Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase Ⅳ Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee.

This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and CENATONE tablet in the treatment of osteoarthritis of the knee.

Start Date24 Feb 2014

Sponsor / Collaborator

Pionex Management Group Pharm Co., Ltd.

NCT01768468

/ CompletedPhase 4

Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.

Start Date01 Oct 2012

Sponsor / Collaborator

Pionex Management Group Pharm Co., Ltd.

NCT01576419

/ CompletedPhase 3

Double Blinded, Randomized, Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients

The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients.
This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308.
non-inferiority margin: 8mm

Start Date01 Jan 2010

Sponsor / Collaborator

Pionex Management Group Pharm Co., Ltd.

100 Clinical Results associated with PG-201

100 Translational Medicine associated with PG-201

100 Patents (Medical) associated with PG-201

Literatures (Medical) associated with PG-201

15 Nov 2024·Medicine

Comparison of a fixed-dose combination of Celecoxib/PG201 [Layla®] versus co-administration of individual formulations in healthy participants: A randomized trial

Article

Author: Hong, Jang Hee ; Song, Ji Hye ; Jung, Jin-Gyu ; Koh, Hyunsook ; Moon, Hyun-Young ; Sunwoo, Jung

Background:Osteoarthritis (OA) is a prevalent joint disease affecting the spine, hands, hips, knees, and feet. However, definitive drugs for OA are lacking, and current treatments are limited owing to inconvenient administration, inadequate functional improvement, and long-term side effects including gastrointestinal and cardiovascular adverse events. Therefore, in this study, we aimed to assess the pharmacokinetics and safety profiles of PK101, a fixed-dose combination (FDC) comprising PG201, a 12-herb extract used in OA treatment in traditional East Asian medicine, and celecoxib, a selective cyclooxygenase-2 inhibitor, by comparing its administration as an FDC and the corresponding individual formulations in healthy subjects.Patients and methods:A randomized, open-label, single-dose, 2 × 2 crossover design with a cohort of healthy participants. All subjects received a single FDC tablet (405.4 mg PG201 and 100 mg celecoxib) or the individual formulations, with 7-day washout period between administrations. The estimation of maximum plasma concentration and area under the plasma concentration–time curve from time zero to the time of the last quantifiable concentration of celecoxib involved determining the geometric mean ratios and 90% confidence intervals of the FDC compared to its individual formulations.Results:Forty-six participants were enrolled; however, only 44 completed the study. The geometric mean ratios (90% confidence intervals) for the area under the plasma concentration–time curve from time zero to the time of the last quantifiable concentration and maximum plasma concentration of celecoxib were 1.1124 (1.0601–1.1672) and 1.2788 (1.1708–1.3969), respectively. The time of maximum plasma concentration range was 1.0 to 4.0 hours and 1.0 to 6.0 hours (minimum–maximum) for the FDC and individual formulations, respectively. Seven adverse events occurred in 6 subjects.Conclusion:The systemic exposure and safety profiles of the individual and FDC formulations were similar, supporting their potential as an innovative and effective therapeutic approach for OA treatment. All relevant data are within the paper and its Supporting Information files.

01 Apr 2016·Journal of Ethnopharmacology

Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis

Article

Author: Han, Seung-Beom ; Lee, Jae Hyup ; Ha, Chul-Won ; Park, Ye-Soo ; Won, Ye-Yeon ; Min, Byung-Woo ; Park, Yong-Beom

ETHNOPHARMACOLOGICAL RELEVANCEThis prospective, randomized, double-blinded, double-dummy, multicenter study compared the efficacy and safety of PG201 (Layla®), a new product from extracts of 12 plant sources and SKI306X (Joins®) which have been well investigated and in relatively wide usage among herbal medicine, for the treatment of patients with knee osteoarthritis.AIM OF THE STUDYTo compare the efficacy and safety of PG201 and SKI306X in patients with knee osteoarthritis.MATERIALS AND METHODSA prospective, double-blinded multicenter study was conducted in 124 patients with Kellgren and Lawrence grade 2-3 knee osteoarthritis. Patients were randomly assigned to receive 600mg of PG201 (300mg, twice daily) and 600mg of SKI306X placebo (200mg, thrice daily) or 600mg of SKI306X (200mg, thrice daily) and PG201 placebo (300mg, twice daily) for 12 weeks. The primary outcome was the improvement of pain by week 8 as assessed by the 100-mm pain visual analog scale (VAS). Secondary outcomes included pain VAS improvement level at week 12, pain VAS improvement rate at weeks 8 and 12, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) improvement level at weeks 8 and 12, the improvement of the quality of life (EQ-5D), overall symptom self-assessment score, and rescue medication consumption.RESULTSThe pain VAS improvement at 8 weeks was 14.2±16.2 in the experimental group and 11.9±13.1 in control group (p=0.557), confirming that the experimental group was not inferior to the control group as lower limit (-8.38) of 95% CI of the difference of VAS improvement between two groups was well above the allowed limit (-10 mm). There was no significant difference in all secondary outcomes including pain VAS, WOMAC, EQ-5D, overall symptom self-assessment score, and rescue medication consumption. Adverse events were low and similar between the two groups.CONCLUSIONSThe results of this study showed that PG201 significantly reduced knee pain and improved knee function and were comparable to SKI306X. PG201 can be suggested as an effective treatment of knee osteoarthritis. Trial registration ClinicalTrials.gov:NCT01768468.

01 Feb 2016·Archives of Pharmacal ResearchQ3 · MEDICINE

Constituents of PG201 (Layla®), a multi-component phytopharmaceutical, with inhibitory activity on LPS-induced nitric oxide and prostaglandin E2 productions in macrophages

Q3 · MEDICINE

Article

Author: Ryu, Byeol ; Shin, Ji-Sun ; Jang, Dae Sik ; Kim, Hye Mi ; Lee, Kyung-Tae ; Lee, Woo-Seok ; Kim, Hyun Ji

Fourteen compounds, coumarin (1), demethylsuberosin (2), xanthotoxin (3), psoralen (4), decursinol (5), decursin (6), decursinol angelate (7), chikusetsusaponin IVa (8), chikusetsusaponin IVa methyl ester (9), ethyl caffeate (10), syringaresinol (11), cnidilide (12), farnesol (13), and linoleic acid (14), were isolated from phytopharmaceutical PG201 (Layla(®)) by activity-guided fractionation utilizing inhibitory activity on nitric oxide (NO) production in vitro. The isolates 1-14 were evaluated for their inhibitory activity on LPS-induced NO and prostaglandin E2 (PGE2) productions in RAW 264.7 cells. All the compounds except 14 displayed suppressive effects on LPS-induced NO and PGE2 production with IC50 values ranging from 8 to 60 μM. Among these, compound 10 showed the most potent inhibitory effect on NO production from RAW 264.7 cells with an IC50 value of 8.25 μM. Compounds 2, 9, and 10 exhibited high inhibitory effects on PGE2 production with the IC50 values of 9.42, 7.51, and 6.49 μM, respectively. These findings suggest that compounds 2, 9, and 10 are the potential anti-inflammatory active constituents of PG201 and further study may be needed to explain their mechanism of action.

100 Deals associated with PG-201

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Osteoarthritis	South Korea	Pionex Management Group Pharm Co., Ltd.	13 Mar 2012

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Preclinical	South Korea	Pionex Management Group Pharm Co., Ltd.	01 Jan 2010

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