aceclofenac/eperisone controlled-release (NVP-1203) / NVP Healthcare - LARVOL DELTA

Evaluation of the efficacy and safety of NVP-1203 and aceclofenac in patients with acute low back pain and muscle spasm: A randomized, double-blind, active-controlled, parallel, multicenter, phase 3 clinical trial. (PubMed, Eur Rev Med Pharmacol Sci) - "The mean change in the 100 mm pain movement/resting VAS scores from baseline to day 7 was -49.7 ± 21.5/-41.0 ± 19.4 mm and -38.8 ± 18.9/-33.8 ± 18.0 mm for the NVP-1203 and Airtal groups, respectively. The differences between the two groups were statistically significant (movement, p < 0.0001; resting, p = 0.0002). Differences in least-square (LS) mean change of the 100 mm pain movement/resting VAS score between the two groups using the analysis of covariance (ANCOVA) model was -10.2/-7.4 mm, and the upper limit of the 95% confidence interval was -6.44/-4.16 mm."

Clinical • Journal • P3 data • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain (clinicaltrials.gov) - P3; N=421; Completed; Sponsor: Navipharm Corporation; Recruiting ➔ Completed

Clinical • Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain (clinicaltrials.gov) - P3; N=420; Recruiting; Sponsor: Navipharm Corporation; Trial completion date: Jan 2021 ➔ Jun 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain (clinicaltrials.gov) - P3; N=420; Recruiting; Sponsor: Navipharm Corporation; Trial completion date: Jul 2020 ➔ Jan 2021; Trial primary completion date: Jul 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Navipharm Corporation; Not yet recruiting ➔ Completed

Clinical • Trial completion

Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain (clinicaltrials.gov) - P3; N=420; Recruiting; Sponsor: Navipharm Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Navipharm Corporation

Clinical • New P1 trial

Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain (clinicaltrials.gov) - P2; N=91; Completed; Sponsor: Navipharm Corporation; Recruiting ➔ Completed

Clinical • Trial completion

Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain (clinicaltrials.gov) - P3; N=420; Not yet recruiting; Sponsor: Navipharm Corporation

Clinical • New P3 trial

Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203 (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Navipharm Corporation; N=30 ➔ 0; Trial completion date: Dec 2017 ➔ Dec 2019; Suspended ➔ Withdrawn; Trial primary completion date: Dec 2017 ➔ Dec 2019

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal

A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203 (clinicaltrials.gov) - P1; N=39; Completed; Sponsor: Navipharm Corporation; Not yet recruiting ➔ Completed; Trial completion date: Jul 2019 ➔ Feb 2019

Clinical • Trial completion • Trial completion date