Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine whether the fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium is more effective in the treatment of an acute episode of mechanical postural low back pain than Voltaren®. Will be randomized 110 participants of both sexes, aged 18 years or older and less than 65 years of age with an acute episode of mechanical postural low back pain and they will be allocated to one of two treatment groups: Group 1: Fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium; or Group 2: Voltaren®


Clinical Trial Description

The fixed combination of orphenadrine 35mg, acetaminophen 325mg, caffeine 65mg and diclofenac sodium 50mg aims to provide patients with anti-inflammatory, analgesic and myorelaxant action with adequate safety and tolerability profile.

Diclofenac is a nonsteroidal anti-inflammatory with analgesic, anti-inflammatory and antipyretic action and is effective in the treatment of a variety of acute and chronic inflammatory and painful conditions. Its anti-inflammatory effect occurs by inhibiting the synthesis of prostaglandins by inhibiting COX-1 and COX-2 in an equipotent manner.

Orphenadrine, on the other hand, is a central acting muscle relaxant that has analgesic and anticholinergic effects. It presents clinical efficacy in the treatment of painful conditions associated to pictures such as strains and sprains, especially of acute character, among other musculoskeletal conditions that present with pain and muscular contracture.

Concerning acetaminophen, its a drug with analgesic and antipyretic action as well as anti-inflammatory properties. It is widely used in a wide variety of pathologies with a focus on the treatment of mild to moderate pain. It is a non-opioid analgesic with action in the inhibition of cyclooxygenase and consequently in the production of prostaglandins, with potency similar to that of aspirin. It is the analgesic of choice for children, the elderly and pregnant women. It has been used successfully in the treatment of back pain. The association between acetaminophen and orphenadrine is known and clinically effective in analgesia, as well as the combination of acetaminophen and diclofenac, which also provides clinical efficacy in the management of acute postoperative pain.

Lastly, caffeine, an alkaloid belonging to the group of methylxanthines, is an agonist that competes with adenosine receptors, acting in these receptors in very varied areas, such as throughout the peripheral circulation and in the cerebral cortex. Caffeine enhances the effects of other analgesics, improves acetaminophen pharmacokinetics, and induces mood changes. All these mechanisms may contribute to improve the analgesic action of acetaminophen.

The association of non-steroidal anti-inflammatory, muscle relaxant, analgesic and caffeine in the symptomatic treatment of painful conditions associated with the musculoskeletal system is quite old. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02985671
Study type Interventional
Source Ache Laboratorios Farmaceuticos S.A.
Contact Elisangela C Rorato, Specialist
Phone +55 11 2608-6130
Email elisangela.rorato@ache.com.br
Status Not yet recruiting
Phase Phase 3
Start date January 2021
Completion date October 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06009263 - Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP N/A
Completed NCT05052840 - Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain N/A
Completed NCT04562701 - Relationship Between Hamstring Length and Gluteus Maximums in Mechanical Low Back Pain
Not yet recruiting NCT04542798 - CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting N/A
Terminated NCT02276794 - Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain N/A
Recruiting NCT01940744 - Prescriptive Mobilization Versus a Pragmatic Mobilization N/A
Completed NCT02226692 - Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain N/A
Recruiting NCT05616702 - Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain N/A
Recruiting NCT02622789 - Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain N/A
Not yet recruiting NCT05088031 - Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain
Not yet recruiting NCT06330792 - Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain N/A
Completed NCT03949179 - Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model
Completed NCT01591824 - Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain N/A
Completed NCT03517410 - Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Low Back Pain
Completed NCT02239289 - Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients N/A
Recruiting NCT05404997 - Comparative Effects of SWT and Maitland LM in Mechanical LBP N/A
Completed NCT05475912 - Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain N/A
Not yet recruiting NCT04726579 - CBD Oil in Mechanical Back Pain
Recruiting NCT02491879 - Ketoprofen Gel vs Placebo in Low Back Pain Phase 4
Completed NCT01557049 - Global Postural Reeducation in Chronic Low Back Pain N/A