Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

NCT02168010 Phase 3 COMPLETED

The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in patients with low back pain for 3 months after surgical treatment. It is a randomized, placebo-controlled, double blind, multi-center phase III clinical trial. Patients with chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and 70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4 measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required to score their pain with pain VAS and to have regular blood, urine, and renal/liver function tests. The changes of the pain VAS at day 21 are compared between groups.

Details

Lead sponsor	VanWorld Pharmaceutical (Rugao) Company Limited
Phase	Phase 3
Status	COMPLETED
Enrolment	584
Start date	2013-10
Completion	2014-07

Conditions

• Low Back Pain

Interventions

• Analgecine
• Neurotropin
• Placebo

Primary outcomes

• Change of Visual Analysis Scale on Pain — Day 0, 7, 14 and 21

Countries

China