Conditions: Low Back Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 138
Healthy volunteers: no

Brief summary:
To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in patients with acute low back pain. To investigate the safety and tolerability of repeated use of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).

Detailed description:

Arms:
arm 1: 2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period arm 2: 2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Interventions: intervention 1: nonivamide + nicoboxil (Finalgon cream) intervention 2: placebo matching nonivamide + nicoboxil (Finalgon cream)
Intervention descriptions: intervention 1: 2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period intervention 2: 2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Protocol document: