Acute Low Back PainPhase 2NCT00952068
A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day
A Phase 2 study testing Tramadol Contramid® OAD 200mg in people with Acute Low Back Pain, run by Labopharm Inc..
Trial summary
The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- Tramadol Contramid® OAD 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Apr 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females in generally good health aged 18-80 years with acute low back pain are eligible for this study.
- Patients must have pain of moderate to severe intensity on the patient rating of pain intensity scale without analgesia.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- Must have signed and dated an REB-approved written Informed Consent form which was also signed and dated by the Investigator prior to study participation.
Who cannot join
- Known history or symptoms suspicious of:
- Spinal fracture
- Cancer (i.e. constitutional symptoms such as recent unexplained chills or weight loss)
- Spinal infection (e.g. IV drug abuse, immunosuppression)
- Cauda equina syndrome
- Spina bifida
Show all 28Show fewer
- Foot drop
- Spinal surgery within 1 year of study entry
- Body Mass Index (BMI) > 37
- Continuous chronic back pain
- More severe pain in a region other than the lower back
- Treatment of the back pain with non-pharmacological therapy (e.g. acupuncture chiropractic adjustment, Transcutaneous Electrical Nerve Stimulation, physiotherapy etc.) in the 3 weeks prior to study entry
- Use of any sedative hypnotics, topical preparations/medications and anaesthetics or muscle relaxants within 5 half-lives of the dose of study medication
- Use of any analgesic within 6 hours of the dose of study medication. In rare cases, if a patient is in moderate to severe pain despite having taken a short-acting analgesic and if at least 2 hours have passed since the dose of short-acting analgesic, the patient may be entered.
- A major illness, requiring hospitalisation during the 3 months before commencement of the screening period
- Unwillingness to stop taking pain medication other than the study medication
- Previous failure of treatment with tramadol or discontinuation of treatment with tramadol due to adverse events
- Treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors (SSRIs); serotonin-norepinephrine reuptake inhibitors (SNRIs) or any other drug that reduces seizure threshold
- Treatment with another investigational agent within the last 30 days
- History of seizure disorder other than Infantile Febrile Seizures
- Previous or current opioid dependency
- Bowel disease causing malabsorption
- Pregnant or lactating women
- Known significant liver disease or symptoms of significant liver disease
- Known significant renal disease or symptoms of significant renal disease
- Current or past substance abuse or dependence, other than nicotine
- Allergy to tramadol or any structurally similar drugs (e.g. opiates)
- Any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures
About this study
The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol Contramid® OAD.
- Conditions
- Acute Low Back Pain
- Being tested
- Tramadol Contramid® OAD 200mg
- Keywords
- Back Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Contramid® OAD 200mgDrug
1 Tramadol Contramid® OAD 200mg tablet daily.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol Contramid® OAD 200mg | Experimental | 1 Tramadol Contramid® OAD 200mg tablet daily. Receives: Drug: Tramadol Contramid® OAD 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of Perceptible Pain Relief
Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.
Measured: 6 hours
Secondary outcomes (4)
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Pain intensity rating at baseline, time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. "What is your current level of pain intensity?" 0=none, 1=mild, 2=moderate, 3=severe. Missing data were imputed using Last Observation Carried Forward (LOCF).
Measured: Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Pain relief rating at time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. " How would you rate the pain relief the study medication has given you?" ranging from 0=none to 4=complete relief. Missing data were imputed using Last Observation Carried Forward (LOCF).
Measured: 3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose
PK samples were drawn at the end of the Screening Phase, at the onset of perceptible pain relief, at 3 hours and at 6 hours post-dose or if the patient discontinues early. PK samples were always drawn after the completion of the patient ratings of pain relief and of pain intensity scales. They were processed in a central laboratory and the plasma levels of tramadol were collected.
Measured: Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose
Number of Participants With Adverse Events
All adverse events reported during treatment with study drug were considered and reported as treatment emergent adverse events (TEAE) whether or not medication for this adverse event was required by the participant and were summarized in the same table.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952068
- Sponsor's protocol ID
- MDT2-002
- Other IDs
- NCT00952068
- Status last verified
- Apr 2012
- First submitted
- 16 Apr 2009
- Last updated
- 30 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sarbu A, Radulescu F, Robertson S, Bouchard S. Onset of analgesic effect and plasma levels of controlled-release tramadol (Tramadol Contramid once-a-day) 200-mg tablets in patients with acute low back pain. J Opioid Manag. 2008 Sep-Oct;4(5):285-92. doi: 10.5055/jom.2008.0032.
PubMed 19070266
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day
- ClinicalTrials.gov ID
- NCT00952068
- Acronym / sponsor ID
- MDT2-002
- Conditions
- Acute Low Back Pain
- Keywords
- Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Posted 4 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol Contramid® OAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tramadol Contramid® OAD 200mg | Experimental | Drug: Tramadol Contramid® OAD 200mg1 Tramadol Contramid® OAD 200mg tablet daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females in generally good health aged 18-80 years with acute low back pain are eligible for this study.
- Patients must have pain of moderate to severe intensity on the patient rating of pain intensity scale without analgesia.
- Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
- Must have signed and dated an REB-approved written Informed Consent form which was also signed and dated by the Investigator prior to study participation.
Key exclusion criteria (28 listed)
- Known history or symptoms suspicious of:
- Cauda equina syndrome
- Spina bifida
- Foot drop
- Spinal surgery within 1 year of study entry
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 |
|---|---|---|
| Tramadol Contramid® OAD 200mg1 Tramadol Contramid® OAD 200mg tablet daily. | Drug | Tramadol Contramid® OAD 200mg |
Primary outcome
Time to Onset of Perceptible Pain Relief
Time frame: 6 hours
Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.
4 secondary outcomes
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Time frame: Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Time frame: 3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose
Time frame: Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose
Number of Participants With Adverse Events
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19070266Sarbu A, Radulescu F, Robertson S, Bouchard S. Onset of analgesic effect and plasma levels of controlled-release tramadol (Tramadol Contramid once-a-day) 200-mg tablets in patients with acute low back pain. J Opioid Manag. 2008 Sep-Oct;4(5):285-92. doi: 10.5055/jom.2008.0032.
- Approved labellingLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tramadol Contramid® OAD 200mg in people with Acute Low Back Pain, run by Labopharm Inc..
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 4 inclusion and 28 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 30 Apr 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Onset of Perceptible Pain Relief (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952068, which also lists 1 linked publication.
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 30 Apr 2012.