Trials Sponsors Conditions Drugs Pricing

Conditions

Postural Low Back Pain Mechanical Low Back Pain

Keywords

Postural Low Back PainMechanical Low Back PainLow Back Painacetaminophencaffeineorphenadrinediclofenac 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.

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 sodiumDrug: 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

Interventions

orphenadrine, acetaminophen, caffeine and diclofenac sodiumDrug

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

Also known as: experimental drug

Experimental Drug & Voltaren Placebo

Diclofenac Sodium 50 MGDrug

Voltaren (diclofenac sodium 50mg) tablet

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
orphenadrine, acetaminophen, caffeine and diclofenac sodium
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Ache Laboratorios Farmaceuticos S.A.
Industrylead

MeSH Terms

Conditions

Low Back Pain

Interventions

OrphenadrineAcetaminophenCaffeineDiclofenacDrugs, Investigational

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthylaminesAmines

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

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

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 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 2021

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;
+9 more criteria

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.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Experimental Drug & Voltaren Placebo

Voltaren® + Experimental Drug Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Experimental Drug & Voltaren Placebo

Voltaren® + Experimental Drug Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record