Low Back PainPhase 3TIOKETNCT00679146
Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain
A Phase 3 study testing Thiocolchicoside+Ketoprofen and Thiocolchicoside in people with Low Back Pain, run by Sanofi at 6 sites in 6 countries.
Trial summary
Primary Objective : To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Thiocolchicoside+Ketoprofen and Thiocolchicoside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Apr 2008to Jun 2009
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non specific low back pain with an acute episode of recent onset (<48 hours) defined by average pain within the last 24 hours equal or more than 50 mm on the Visual Analogue Scale (VAS)
- Low back pain of diagnosis category 1 (low back pain radiating no farther than the intergluteal fold) or 2 (low back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain
Who cannot join
- Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders,
- Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain
- History of inflammatory arthritis of large joints,
- History of seizure disorders,
- History of malignant tumour,
- Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids,
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- Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission,
- Psychiatric or mental diseases,
- Immunosuppression, HIV,
- Inclusion in another study in the past six months or previous inclusion in this study,
- History of alcohol, drugs or narcotics abuse
- Recent history of violent trauma,
- Constant progressive, non mechanical pain (no relief with bed rest),
- Thoracic pain,
- Patient systemically unwell,
- Unexplained weight loss,
- Widespread neurological symptoms (including cauda equine syndrome),
- Structural deformity
- Fever,
- Clinical significant renal dysfunction defined by Creatinine > 1.5 UNL,
- Clinically significant hepatic dysfunction defined by:
- Total Bilirubin > 2 UNL
- SGOT (AST) > 1.5 UNL
- SGPT (ALAT) > 1.5 UNL
- Alkaline Phosphatase > 1.5 UNL
- Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy...) within the last 48 hours.
- Pregnancy, breast feeding or women of childbearing potential not using efficient contraception. Patient with Intra Uterine Device should use another form of contraception as the efficacy of the IUD may be reduced by ketoprofen.
- Known or suspected hypersensitivity to thiocolchicoside
- Uncontrolled heart failure,
- Arterial Hypertension (SBP>140 mmHg or DBP >90 mmHg),
- Stroke or myocardial infarction in the past,
- Myopathy
- Myasthenia,
- History of active peptic ulcer or gastrointestinal (GI) bleeding, history of gastric pain with NSAIDs,
- History of NSAID/aspirin-induced asthma,
- Known or suspected hypersensitivity to ketoprofen.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Efficacy and Safety of a Fixed Combination (Thiocolchicoside 8 mg + Ketoprofen 100 mg ) Compared to Thiocolchicoside 8 mg Administered Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain
Primary Objective :
To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset
Secondary Objective :
To compare the safety of the oral combination to that of oral TCC alone
- Conditions
- Low Back Pain
- Being tested
- Thiocolchicoside+Ketoprofen, Thiocolchicoside
- 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.
Thiocolchicoside+KetoprofenDrug
1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d
ThiocolchicosideDrug
2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d Receives: Drug: Thiocolchicoside+Ketoprofen |
| 2 | Active comparator | 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d Receives: Drug: Thiocolchicoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain within the last 24 hours (VAS)
Measured: at D3 visit
Secondary outcomes (1)
Average pain within the last 24 hours (VAS)
Measured: at D7 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionJun 2009
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margarita MURRIETA-AGUTTES, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679146
- Sponsor's protocol ID
- KETOP_R_02693
- Acronym
- TIOKET
- Status last verified
- Jun 2010
- First submitted
- 6 May 2008
- Last updated
- 11 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Fixed Combination (Thiocolchicoside 8 mg + Ketoprofen 100 mg ) Compared to Thiocolchicoside 8 mg Administered Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT00679146
- Acronym / sponsor ID
- TIOKET / KETOP_R_02693
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 May 2008 (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.
Primary Objective :
To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset
Secondary Objective :
To compare the safety of the oral combination to that of oral TCC alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Thiocolchicoside+Ketoprofen1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d |
| 2 | Active comparator | Drug: Thiocolchicoside2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non specific low back pain with an acute episode of recent onset (<48 hours) defined by average pain within the last 24 hours equal or more than 50 mm on the Visual Analogue Scale (VAS)
- Low back pain of diagnosis category 1 (low back pain radiating no farther than the intergluteal fold) or 2 (low back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain
Key exclusion criteria (37 listed)
- Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders,
- Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain
- History of inflammatory arthritis of large joints,
- History of seizure disorders,
- History of malignant tumour,
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 |
|---|---|---|
| Thiocolchicoside+Ketoprofen1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d | Drug | 1 |
| Thiocolchicoside2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d | Drug | 2 |
Primary outcome
Average pain within the last 24 hours (VAS)
Time frame: at D3 visit
1 secondary outcome
Average pain within the last 24 hours (VAS)
Time frame: at D7 visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
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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.
Margarita MURRIETA-AGUTTES study director
Sanofi
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thiocolchicoside+Ketoprofen and Thiocolchicoside in people with Low Back Pain, run by Sanofi at 6 sites in 6 countries.
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 2 inclusion and 37 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: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil, Colombia, Egypt, Guatemala, Mexico and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain within the last 24 hours (VAS) (time frame: at D3 visit). 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 11 Jun 2010.