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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.

NCT02985671 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-09-03

No results posted yet for this study

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®

Conditions

  • Postural Low Back Pain
  • Mechanical 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

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Mauro C Junior, M.D. · Allergisa Search Dermato Cosmetic Ltda.

  • Morton A Scheinberg, M.D. · AACD - Association of Assistance to the Disabled Child

  • Pedro Henrique I Pohl, M.D. · Center for Multidisciplinary Studies CEPES

  • Pérola G Plapler, M.D. · Clinical Research Center IOT HCFMUSP

  • Suely S Roizenblatt · CDEC Brazil - Center for the Development of Clinical Studies Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2021-09-30
Completion
2021-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985671 on ClinicalTrials.gov