Low Back PainPhase 4NCT00917436
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
A Phase 4 study testing Thiocolchicoside in people with Low Back Pain, run by Sanofi at 1 site in India.
Trial summary
To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Thiocolchicoside
- How many people
- 183 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2004to Jul 2005
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute low back pain of recent onset (less than 7 days) and defined by spontaneous pain intensity at rest more than or equal to 50mm of the visual analog scale.
- Presence of lumbar muscular contracture
Who cannot join
- Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
- Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
- Renal failure (serum creatinine > 160 µmol/l or > 1.80 mg/dl) and/or severe hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase and/or total bilirubin > 2 Upper normal limit).
- Positive history of cerebro-vascular accidents or myocardial infarction in the six months prior the inclusion.
- Severe heart failure.
- Myopathy / myasthenia.
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- Patients treated during two days prior to inclusion with steroidal agents.
- Known or suspected hypersensitivity to thiocolchicoside.
- Known or suspected hypersensitivity to nonsteroidal anti-inflammatory drugs
- History of active peptic ulcer or gastro intestinal bleeding.
- History of nonsteroidal anti-inflammatory drugs induced allergic asthma.
- Concomitant treatment with 2-agonists (i.e. clonidine).
- Pregnant or breast feeding women.
- Females of child bearing potential, not taking adequate contraception.
- Patients with history of alcohol, drugs or narcotics abuse.
- Previous inclusion in this study or in another study in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.
- Conditions
- Low Back Pain
- Being tested
- 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.
ThiocolchicosideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score evaluated by patient-rated visual analog scale: the levels of spontaneous pain is indicated by the patient by means of a 10 centimetre non-graduated scale, in which the patient could estimate the intensity of pain
Measured: During patient visits: day 1, day 3 and day 5 to 10
Secondary outcomes (3)
Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor).
Measured: During patient visits: day 1, day 3 and day 5 to 10
Disability Questionnaire (Roland Morris)
Measured: During patient visits: day 1, day 3 and day 5 to 10
Physician rated Clinical Global Impression Scale
Measured: During patient visits: day 1, day 3 and day 5 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startDec 2004
- Primary completionJul 2005
- Study completionJul 2005
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 4
- Primary purpose
- Treatment
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manish MISTRY, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917436
- Sponsor's protocol ID
- L_9826
- Status last verified
- Jan 2010
- First submitted
- 8 Jun 2009
- Last updated
- 15 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT00917436
- Acronym / sponsor ID
- L_9826
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 10 Jun 2009 (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.
To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of acute low back pain of recent onset (less than 7 days) and defined by spontaneous pain intensity at rest more than or equal to 50mm of the visual analog scale.
- Presence of lumbar muscular contracture
Key exclusion criteria (16 listed)
- Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
- Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
- Renal failure (serum creatinine > 160 µmol/l or > 1.80 mg/dl) and/or severe hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase and/or total bilirubin > 2 Upper normal limit).
- Positive history of cerebro-vascular accidents or myocardial infarction in the six months prior the inclusion.
- Severe heart failure.
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 | Drug | – |
Primary outcome
Pain score evaluated by patient-rated visual analog scale: the levels of spontaneous pain is indicated by the patient by means of a 10 centimetre non-graduated scale, in which the patient could estimate the intensity of pain
Time frame: During patient visits: day 1, day 3 and day 5 to 10
3 secondary outcomes
Mobility Hand-to-floor distance is evaluated by a simple graduated bar (0 value at floor).
Time frame: During patient visits: day 1, day 3 and day 5 to 10
Disability Questionnaire (Roland Morris)
Time frame: During patient visits: day 1, day 3 and day 5 to 10
Physician rated Clinical Global Impression Scale
Time frame: During patient visits: day 1, day 3 and day 5 to 10
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 15 Jan 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.
Manish MISTRY study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thiocolchicoside in people with Low Back Pain, run by Sanofi at 1 site in India.
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 16 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 15 Jan 2010. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain score evaluated by patient-rated visual analog scale: the levels of spontaneous pain is indicated by the patient by means of a 10 centimetre non-graduated scale, in which the patient could estimate the intensity of pain (time frame: During patient visits: day 1, day 3 and day 5 to 10). 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 15 Jan 2010.