NCT02985671 - To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain. | Biotech Hunter

Enrollment

110

Participants

Timeline

Start Date

January 31, 2021

Primary Completion Date

September 30, 2021

Study Completion Date

October 31, 2021

Conditions

Postural Low Back PainMechanical Low Back Pain

Interventions

DRUG

orphenadrine, acetaminophen, caffeine and diclofenac sodium

orphenadrine 35mg, acetaminophen 325mg, caffeine 65mg and diclofenac sodium 50mg tablet

DRUG

Diclofenac Sodium 50 MG

Voltaren (diclofenac sodium 50mg) tablet

DRUG

Placebo (for experimental drug)

tablet without active substances, manufactured to mimic experimental product tablet

DRUG

Placebo (for Voltaren)

tablet without active substances, manufactured to mimic Voltaren 50mg tablet