Trial intelligence / Profile preview

LAYLA vs CENATONE in Knee Osteoarthritis

NCT02049606Phase 4

Key facts

Status: Completed
Start: Feb 2014
Primary completion: May 2015
Countries: 1
Sponsor: PMG Pharma
Modality: Small Molecules

Drugs: PG201
Conditions: osteoarthritis (OA)

Overview

Phase 4, randomised, double-blind trial of PG201 in osteoarthritis (OA) (2 arms), sponsored by PMG Pharma. Primary endpoint: Visual Analog Scale for Pain at 8 weeks. Started Feb 2014; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

LAYLA Arm
LAYLA tablet (1 tablet bid)
CENATONE Arm
CENATONE tablet (nabumetone 500mg, 2 tablets qd)

Who it enrols

Patients aged 40-80 with stable osteoarthritis of the knee (Kellgren & Lawrence grade 1-3) and moderate to severe pain (VAS 40-80mm).

Endpoints

Primary

Visual Analog Scale for Pain8 weeks

Secondary

Visual Analog Scale for Pain Change Rate8 weeks
Western Ontario and McMaster Universities Arthritis Index8 weeks
EuroQol-5 Dimension8 weeks
Patient self-assessed overall symptom score8 weeks

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