Low Back PainPhase 3NCT01421433
A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
A Phase 3 study testing Tandrilax and Dolamin Flex in people with Low Back Pain, run by Farmoquimica S.A. at 1 site in Brazil.
Trial summary
Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Tandrilax and Dolamin Flex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Jan 2013
- 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
- Informed of the nature of the study and given written informed consent
- Patients with mild to moderate lumbago
- Aged between 18 and 65 years old
Who cannot join
- Known allergy or sensitivity to drug components
- Treatment with another anti inflammatory or corticoid
- Treatment with oral anticoagulants
- Treatment with oxidase monoamine 2 weeks before the study
- Treatment with methotrexate
- Stomach or duodenal ulcer and gastritis
Show all 13Show fewer
- Dehydration
- Acute myocardial infarction or heart failure
- Hyperthyroidism
- Pregnant or lactating patients
- Treatment with lithium
- User of alcohol and barbiturates
- Hepatic or renal failure
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital São Luiz
São Paulo, São Paulo, 05673-050
Rogerio T. Silva, 551181716767, rogerio@neo.org.br
About this study
Official title: Non Inferiority,Phase III,Multicentric,Double Blind,Randomized,Parallel Study,Comparing Dolamin Flex (Lysine Clonixinate+Cyclobenzaprine) and Tandrilax(Caffeine +Carisoprodol+Diclofenac+Paracetamol)in Pain Reduction in Patients With Lumbago
Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.
Read the detailed description
Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis.
- Conditions
- Low Back Pain
- Being tested
- Tandrilax, Dolamin Flex
- Keywords
- Clonixin, Anti-Inflammatory Agents, Non-Steroidal, Cyclooxygenase Inhibitors, Lysine, L-Lysine, Lysine Acetate, Lysine Hydrochloride, Amitriptyline
- 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.
TandrilaxDrug
Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
Dolamin FlexDrug
Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Tandrilax | Active comparator | Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol) Receives: Drug: Tandrilax |
| Dolamin Flex | Experimental | Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine) Receives: Drug: Dolamin Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain average reduction
The metric that will be used is Pain Analog Visual Scale (PAVS), that it is a graphical representation with values 0-10.
To use the PAVS, the principal investigator should question the patient regarding their pain level, and the value 0 (zero) means no pain and the value 10 (ten) indicates the maximum pain level.
Measured: 7 days
Secondary outcomes (1)
Identification of possible gastrointestinal effects
The metric that will be used is checking the safety data reported by the patient in the Patient Diary and / or using data reported by patients by Phone Call.
A diary will be given for the patient, to make notes about possible gastrointestinal adverse events.
The principal investigator should call to the patient to know about possible gastrointestinal adverse effects of the drug.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startMay 2012
- Primary completionAug 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmagenix Projetos em Medicina Farmacêutica Ltda.
- Responsible party
- Sponsor
- Investigators
- Rogerio T. Silva, Phd, Principal investigator, Hospital São Luiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421433
- Sponsor's protocol ID
- FQM 01/11
- Status last verified
- Mar 2012
- First submitted
- 18 Aug 2011
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Inferiority,Phase III,Multicentric,Double Blind,Randomized,Parallel Study,Comparing Dolamin Flex (Lysine Clonixinate+Cyclobenzaprine) and Tandrilax(Caffeine +Carisoprodol+Diclofenac+Paracetamol)in Pain Reduction in Patients With Lumbago
- ClinicalTrials.gov ID
- NCT01421433
- Acronym / sponsor ID
- FQM 01/11
- Conditions
- Low Back Pain
- Keywords
- Clonixin, Anti-Inflammatory Agents, Non-Steroidal, Cyclooxygenase Inhibitors, Lysine, L-Lysine, Lysine Acetate, Lysine Hydrochloride, Amitriptyline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Collaborators
- Pharmagenix Projetos em Medicina Farmacêutica Ltda.
- Study start
- May 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 22 Aug 2011 (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.
Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.
Detailed description
Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tandrilax | Active comparator | Drug: TandrilaxReference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol) |
| Dolamin Flex | Experimental | Drug: Dolamin FlexTest product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed of the nature of the study and given written informed consent
- Patients with mild to moderate lumbago
- Aged between 18 and 65 years old
Key exclusion criteria (13 listed)
- Known allergy or sensitivity to drug components
- Treatment with another anti inflammatory or corticoid
- Treatment with oral anticoagulants
- Treatment with oxidase monoamine 2 weeks before the study
- Treatment with methotrexate
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 |
|---|---|---|
| TandrilaxTandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days. | Drug | Tandrilax |
| Dolamin FlexDolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days. | Drug | Dolamin Flex |
Primary outcome
Pain average reduction
Time frame: 7 days
The metric that will be used is Pain Analog Visual Scale (PAVS), that it is a graphical representation with values 0-10. To use the PAVS, the principal investigator should question the patient regarding their pain level, and the value 0 (zero) means no pain and the value 10 (ten) indicates the maximum pain level.
1 secondary outcome
Identification of possible gastrointestinal effects
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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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.
Rogerio T. Silva, Phd principal investigator
Hospital São Luiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tandrilax and Dolamin Flex in people with Low Back Pain, run by Farmoquimica S.A. at 1 site in Brazil.
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 13 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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain average reduction (time frame: 7 days). 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 8 Mar 2012.