Back to resultsA 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
Primary Purpose
Acute Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tramadol Contramid® OAD 200mg
Sponsored by
About this trial
This is an interventional treatment trial for Acute Low Back Pain focused on measuring Back Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tramadol Contramid® OAD 200mg
Arm Description
1 Tramadol Contramid® OAD 200mg tablet daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00952068
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Labopharm Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 dose administration of 200 mg of Tramadol Contramid® OAD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain
Keywords
Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tramadol Contramid® OAD 200mg
Arm Type
Experimental
Arm Description
1 Tramadol Contramid® OAD 200mg tablet daily.
Intervention Type
Drug
Intervention Name(s)
Tramadol Contramid® OAD 200mg
Intervention Description
1 Tramadol Contramid® OAD 200mg tablet daily.
Primary Outcome Measure Information:
Title
Time to Onset of Perceptible Pain Relief
Description
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.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Description
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).
Time Frame
Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief
Title
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Description
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).
Time Frame
3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief
Title
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose
Description
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.
Time Frame
Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
19070266
Citation
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.
Results Reference
result
Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
Description
Approved labelling
Learn more about this trial
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
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