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 | Unknown Phase 3

• 1 other identifier: ACH-TND-03(12/14)
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Postural Low Back Pain; Mechanical Low Back Pain; Low Back Pain; acetaminophen; caffeine; orphenadrine; diclofenac sodium

Outcome Measures

Primary Outcomes (1)

• Superiority of the fixed association of orfenadrine 35 mg, acetaminophen 325 mg, caffeine 65 mg and diclofenac sodium 50 mg, compared to Voltaren® in the treatment of the acute mechanical postural low back pain.

  The primary efficacy variable was the absolute variation of pain intensity measured by the EVA - Visual Analogue Scale of 100mm (0mm = no pain and 100mm = maximum pain) in relation to Baseline (V0), defined as EVA72-0 = (EVA72 - EVA0).

  72 hours (± 7 hours) after initiation of treatment.

Secondary Outcomes (12)

• Relief of pain in the treatment of acute postural mechanical low back pain throughout treatment.

  15', 30', 45', 60', 90', 120', 72h (±7h) and 168h (+48h) after the first administration of the drug for which the study participant was randomized.

• Intensity of pain in the treatment of acute postural mechanical low back pain throughout treatment.

  24 hours and 48 hours after the first administration of the drug for which the study participant was randomized

• Need for rescue medication to control acute pain between treatment groups during the study period.

  07 days

• Number of rescue medication tablets used daily by the research participant in each treatment group.

  07 days

• Evaluation of the functional incapacity of the research participants.

  07 days

Study Arms (2)

Experimental Drug & Voltaren Placebo

EXPERIMENTAL

Orphenadrine + acetaminophen + caffeine + diclofenac sodium \& Placebo of Voltaren 01 tablet of experimental drug (orphenadrine 35mg, acetaminophen 325mg, caffeine 65mg and diclofenac sodium 50mg) + 01 tablet of placebo of Voltaren, to be administrated orally, three times a day, respecting the interval of 08 hours between administrations, during 7 days.

Drug: orphenadrine, acetaminophen, caffeine and diclofenac sodium; Drug: Placebo (for Voltaren)

Voltaren® + Experimental Drug Placebo

ACTIVE COMPARATOR

Voltaren \& Placebo of Orphenadrine + acetaminophen + caffeine + diclofenac sodium 01 tablet of Voltaren + 01 tablet of placebo of experimental drug (orphenadrine, acetaminophen, caffeine and diclofenac sodium), to be administrated orally, three times a day, respecting the interval of 08 hours between administrations, during 7 days.

Drug: Diclofenac Sodium 50 MG; Drug: Placebo (for experimental drug)

Interventions

orphenadrine, acetaminophen, caffeine and diclofenac sodium DRUG

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

Also known as: experimental drug

Experimental Drug & Voltaren Placebo

Diclofenac Sodium 50 MG DRUG

Voltaren (diclofenac sodium 50mg) tablet

Also known as: active comparator, Voltaren

Voltaren® + Experimental Drug Placebo

Placebo (for experimental drug) DRUG

tablet without active substances, manufactured to mimic experimental product tablet

Also known as: Placebo (for orphenadrine + acetaminophen + caffeine + diclofenac sodium)

Voltaren® + Experimental Drug Placebo

Placebo (for Voltaren) DRUG

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

Also known as: Placebo (for Voltaren 50mg)

Experimental Drug & Voltaren Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF);
• Patient with acute low back pain who responds to the pain period less than or equal to 3 days and the minimum value of 40 mm in the VAS;
• Research participants who perform simple RX of lumbosacral spine, with results within the limits of normality for the age group.

You may not qualify if:

• Use of illicit drugs;
• Fertile women who have had a positive pregnancy test in the urine or during gestation or breastfeeding;
• Participants who present with allergic reaction, asthma or urticaria in response to exposure to aspirin, sulfonamides and other NSAIDs;
• Women who do not agree to use acceptable contraceptive methods (oral contraceptive, intravenous contraceptive, intrauterine device (IUD), hormonal implant, barrier methods, hormonal transdermal patch and tubal ligation); except for those surgically sterile (bilateral oophorectomy or hysterectomy), menopause for at least one year, and participants who report not engaging in sexual practices or non-reproductive practices;
• Participants with inflammatory conditions such as any rheumatic condition known as rheumatoid arthritis, osteoarthrosis (grade II, III and IV criteria of Kellgren and Lawrence, Annex IV), ankylosing spondylitis or psoriatic arthritis, chronic pain condition (greater than six weeks), primary or secondary neoplasia, moderate to severe scoliosis (greater than 40º), low back pain as a result of trauma, visceral disorder such as dysmenorrhea or endometriosis;
• Known hypersensitivity to the components of the medicines used during the study;
• Research participants who have had bacterial infection recently (last 90 days), affecting the spine, pelvic or abdominal region; as well as participants with a history of bacterial infection that affected the spine in a chronic way;
• Research participants previously diagnosed with herniated disc, osteoid osteoma, arthroscopic narrowing of the spinal canal, spondyloarthropathies, spondylodiscites, renal calculus, calculitic cholecystitis, endometriosis, prostatitis, abdominal aortic aneurysm, chronic pelvic pain, pyelonephritis, perirenal abscesses and pancreatitis , rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia rheumatica, gout, episodes of acute monoarthritis compatible with pseudogout, Paget's disease, septic arthritis, avascular necrosis, Wilson's disease, hemochromatosis, alkaptonuria, primary osteochondromatosis, iritis, colitis, urethritis and skin rash;
• Participants who present suspected or previous history of esophageal, gastric or duodenal ulcers, or bleeding before the first dose of study medication;
• Research participants presenting with any chronic uncontrolled disease, such as diabetes, hypertension, chronic hepatic or renal disorders, or any clinical condition that, in the opinion of the investigator, may interfere with the study drug;
• Participants presenting with inflammatory bowel disorders (eg, Crohn's disease or ulcerative colitis), significant coagulation defect or history of cardiovascular disease that may prevent the use of NSAIDs, such as congestive heart failure;
• Any finding of clinical observation (clinical / physical assessment) that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical study;
• History of lumbar spine surgery, of any nature;
• Failure to understand and respond to the Roland Morris questionnaire, SF-36 quality of life questionnaire, and Participant's diary, and who do not have an accompanying person to assist him / her;
• Participant with a history of malignant disease without documentation of remission / cure, eg, melanoma, leukemia, lymphoma, myeloproliferative diseases and renal cell carcinoma of any duration should be excluded;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Orphenadrine; Acetaminophen; Caffeine; Diclofenac; Drugs, Investigational

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Pharmaceutical Preparations

Study Officials

• Mauro C Junior, M.D.

  Allergisa Search Dermato Cosmetic Ltda.

  PRINCIPAL INVESTIGATOR

• Morton A Scheinberg, M.D.

  AACD - Association of Assistance to the Disabled Child

  PRINCIPAL INVESTIGATOR

• Pedro Henrique I Pohl, M.D.

  Center for Multidisciplinary Studies CEPES

  PRINCIPAL INVESTIGATOR

• Pérola G Plapler, M.D.

  Clinical Research Center IOT HCFMUSP

  PRINCIPAL INVESTIGATOR

• Suely S Roizenblatt

  CDEC Brazil - Center for the Development of Clinical Studies Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisangela C Rorato, Specialist

CONTACT

+55 11 2608-6130; elisangela.rorato@ache.com.br

Maria Fernanda A Giacomin, M.D.

CONTACT

+55 11 2608-8292; maria.giacomin@ache.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share