Postural Low Back PainPhase 3EiffelNCT02985671
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.
A Phase 3 study testing orphenadrine, acetaminophen, caffeine and diclofenac sodium and Diclofenac Sodium 50 MG in people with Postural Low Back Pain and Mechanical Low Back Pain, run by Ache Laboratorios Farmaceuticos S.A..
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®. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postural Low Back Pain, Mechanical Low Back Pain
- What is being tested?
- orphenadrine, acetaminophen, caffeine and diclofenac sodium and Diclofenac Sodium 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 24Show fewer
- 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;
- Immunosuppressed participants;
- Research participants who perform treatment for osteoporosis;
- Diagnosis of equine cauda syndrome and / or acute severe neurological deficit (presence of motor or sensory changes in the lower limbs and positive Lasegue signal> 60o). Sphincter and anesthesia changes in saddle;
- History of intense pain at minimal effort, progressive pain and night and persistent restriction of movement;
- Research participants with unexplained weight loss (more than 10kg in three months);
- Research participants who are performing some type of oral, physical or topical treatment for low back pain (eg acupuncture, local heat and yoga) and / or initiation of physiotherapy program in the last 2 months before the start of the study;
- Participant in research that has participated in clinical study protocols in the last 12 (twelve) months (CNS Resolution 251, August 7, 1997, item III, subitem J), unless the investigator deems that there may be direct benefit To the same;
- Use of prohibited drugs specified in item 11.2 of this protocol. If the participant makes use of acetylsalicylic acid, used as antiplatelet agent, the maximum dose of 200mg will be allowed;
- Participant who has a relationship of kinship to second degree or bond with employees or employees of Sponsor and Research Center.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: National Clinical Study, Phase III, Multicenter, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Superiority of the Fixed Association (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to the Drug Comparator Voltaren® (Diclofenac Sodium 50mg), in the Treatment of Acute Episode of Mechanical Postural Low Back Pain.
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®
Read the detailed 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.
- Conditions
- Postural Low Back Pain, Mechanical Low Back Pain
- Being tested
- orphenadrine, acetaminophen, caffeine and diclofenac sodium, Diclofenac Sodium 50 MG, Placebo (for experimental drug), Placebo (for Voltaren)
- Keywords
- Postural Low Back Pain, Mechanical Low Back Pain, Low Back Pain, acetaminophen, caffeine, orphenadrine, diclofenac sodium
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orphenadrine, acetaminophen, caffeine and diclofenac sodiumDrug
Also called experimental drug
orphenadrine 35mg, acetaminophen 325mg, caffeine 65mg and diclofenac sodium 50mg tablet
Diclofenac Sodium 50 MGDrug
Also called active comparator, Voltaren
Voltaren (diclofenac sodium 50mg) tablet
Placebo (for experimental drug)Drug
Also called Placebo (for orphenadrine + acetaminophen + caffeine + diclofenac sodium)
tablet without active substances, manufactured to mimic experimental product tablet
Placebo (for Voltaren)Drug
Also called Placebo (for Voltaren 50mg)
tablet without active substances, manufactured to mimic Voltaren 50mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Diclofenac Sodium 50 MG; Drug: Placebo (for experimental drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Absolute variation of pain intensity measured by EVA - Visual Analog Scale of 100mm (0mm = no pain and 100mm = maximum pain) in relation to the basal (V0).
Measured: 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.
pain intensity measured by EVA - Visual Analog Scale of 100mm (0mm = no pain and 100mm = maximum pain) and reported daily in 24 and 48 hours after the first administration of the drug
Measured: 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.
Proportion of participants who needed at least one rescue medication during the study in each treatment group.
Measured: 07 days
Number of rescue medication tablets used daily by the research participant in each treatment group.
Number of rescue medication tablets used daily by the baseline visit participant up to the final study visit in each treatment group as assessed by the research participant's diary.
Measured: 07 days
Evaluation of the functional incapacity of the research participants.
Absolute variation of the total score of the Roland-Morris functional disability questionnaire assessed at visits V1 and VF, in relation to the total baseline score (V0). This questionnaire consists of 24 dichotomous items (0 = No and 1 = Yes) and thus the total score ranges from 0 to 24 points (0 = no complaints and 24 = very serious limitations).
Measured: 07 days
Evaluation of the quality of life of the research participants.
Absolute variation of the score of each SF-36 quality of life questionnaire domain (functional capacity, limitation for physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health) evaluated in the final visit (VF), in relation to the basal score (V0). The result of each domain of this questionnaire ranges from 0 to 100 points (0 = worst state and 100 = best state).
Measured: 07 days
Evaluation of participant satisfaction with treatment.
Satisfaction of the research participant with the treatment, evaluated in the final visit (VF) by means of the visual analog scale of 100 points (EVA of 100mm, being 0mm = totally unsatisfied and 100mm = totally satisfied).
Measured: 07 days
Assess the safety of treatments during the study period.
Incidence of adverse events (AEs) recorded from the first dose of the study drug up to 30 days after the end of treatment, but all adverse events occurring after the signing of the ICF will be collected and reported.
Measured: The first dose of the study drug up to 30 days after the end of treatment.
Assess the safety of treatments during the study period.
Absolute variation of the vital signs measured in visits V1 and VF in relation to the baseline visit (V0).
Measured: Day of V1 and day of VF.
Assess the safety of treatments during the study period.
Proportion of participants with clinical or physical changes, considered relevant according to the researcher's criteria, at visits V1 and VF in relation to the baseline visit (V0).
Measured: Day of V1 and day of VF.
Assess the safety of treatments during the study period.
Proportion of participants with altered laboratory tests, considered clinically relevant according to the researcher's criteria, at the baseline visit (V0) and at the final visit (VF) of the study.
Measured: Day of V0 and day of VF.
Assess the safety of treatments during the study period.
Proportion of participants with alterations in the ECG exam, considered clinically relevant according to the researcher's criteria, observed in visits V0.
Measured: Day of V0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startJan 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro C Junior, M.D., Principal investigator, Allergisa Search Dermato Cosmetic Ltda.Morton A Scheinberg, M.D., Principal investigator, AACD - Association of Assistance to the Disabled ChildPedro Henrique I Pohl, M.D., Principal investigator, Center for Multidisciplinary Studies CEPESPérola G Plapler, M.D., Principal investigator, Clinical Research Center IOT HCFMUSPSuely S Roizenblatt, Principal investigator, CDEC Brazil - Center for the Development of Clinical Studies Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985671
- Sponsor's protocol ID
- ACH-TND-03(12/14)
- Acronym
- Eiffel
- Status last verified
- Sep 2020
- First submitted
- 5 Dec 2016
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Clinical Study, Phase III, Multicenter, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Superiority of the Fixed Association (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to the Drug Comparator Voltaren® (Diclofenac Sodium 50mg), in the Treatment of Acute Episode of Mechanical Postural Low Back Pain.
- ClinicalTrials.gov ID
- NCT02985671
- Acronym / sponsor ID
- Eiffel / ACH-TND-03(12/14)
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Drug & Voltaren Placebo | Experimental | Drug: orphenadrine, acetaminophen, caffeine and diclofenac sodium, Drug: Placebo (for Voltaren)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. |
| Voltaren® + Experimental Drug Placebo | Active comparator | Drug: Diclofenac Sodium 50 MG, Drug: Placebo (for experimental drug)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orphenadrine, acetaminophen, caffeine and diclofenac sodiumAlso: experimental drugorphenadrine 35mg, acetaminophen 325mg, caffeine 65mg and diclofenac sodium 50mg tablet | Drug | Experimental Drug & Voltaren Placebo |
| Diclofenac Sodium 50 MGAlso: active comparator, VoltarenVoltaren (diclofenac sodium 50mg) tablet | Drug | Voltaren® + Experimental Drug Placebo |
| Placebo (for experimental drug)Also: Placebo (for orphenadrine + acetaminophen + caffeine + diclofenac sodium)tablet without active substances, manufactured to mimic experimental product tablet | Drug | Voltaren® + Experimental Drug Placebo |
| Placebo (for Voltaren)Also: Placebo (for Voltaren 50mg)tablet without active substances, manufactured to mimic Voltaren 50mg tablet | Drug | Experimental Drug & Voltaren Placebo |
Primary outcome
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.
Time frame: 72 hours (± 7 hours) after initiation of treatment.
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).
12 secondary outcomes
Relief of pain in the treatment of acute postural mechanical low back pain throughout treatment.
Time frame: 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.
Time frame: 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.
Time frame: 07 days
Number of rescue medication tablets used daily by the research participant in each treatment group.
Time frame: 07 days
Evaluation of the functional incapacity of the research participants.
Time frame: 07 days
Evaluation of the quality of life of the research participants.
Time frame: 07 days
Evaluation of participant satisfaction with treatment.
Time frame: 07 days
Assess the safety of treatments during the study period.
Time frame: The first dose of the study drug up to 30 days after the end of treatment.
Assess the safety of treatments during the study period.
Time frame: Day of V1 and day of VF.
Assess the safety of treatments during the study period.
Time frame: Day of V1 and day of VF.
Assess the safety of treatments during the study period.
Time frame: Day of V0 and day of VF.
Assess the safety of treatments during the study period.
Time frame: Day of V0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro C Junior, M.D. principal investigator
Allergisa Search Dermato Cosmetic Ltda.
Morton A Scheinberg, M.D. principal investigator
AACD - Association of Assistance to the Disabled Child
Pedro Henrique I Pohl, M.D. principal investigator
Center for Multidisciplinary Studies CEPES
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing orphenadrine, acetaminophen, caffeine and diclofenac sodium and Diclofenac Sodium 50 MG in people with Postural Low Back Pain and Mechanical Low Back Pain, run by Ache Laboratorios Farmaceuticos S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisangela C Rorato, Specialist (+55 11 2608-6130, elisangela.rorato@ache.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 72 hours (± 7 hours) after initiation of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.