A Phase 2 interventional study of Tramadol Contramid® OAD 200mg in Acute Low Back Pain, sponsored by Labopharm Inc.. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-30.
Sponsored by Labopharm Inc. · Phase 2, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 47 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Labopharm Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Known history or symptoms suspicious of:
1 Tramadol Contramid® OAD 200mg tablet daily.
Drug: Tramadol Contramid® OAD 200mg
1 Tramadol Contramid® OAD 200mg tablet daily.
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.
Time frame: 6 hours
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).
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
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
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.
Time frame: 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.
Time frame: 6 hours
| Milestone | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Started | 47 |
| Completed | 40 |
| Not completed | 7 |
| Withdrew: Adverse event | 3 |
| Withdrew: Withdrawal by subject | 4 |
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.
| minutes | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Time to Onset of Perceptible Pain Relief | 47 (40 to 51) |
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).
| participants | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Baseline, moderate pain | 34 |
| Baseline, severe pain | 12 |
| Onset of perceptible pain relief, no pain | 4 |
| Onset of perceptible pain relief, mild pain | 23 |
| Onset of perceptible pain relief, moderate pain | 19 |
| 3 hours post-dose, no pain | 12 |
| 3 hours post-dose, mild pain | 25 |
| 3 hours post-dose, moderate pain | 9 |
| 6 hours post-dose, no pain | 24 |
| 6 hours post-dose, mild pain | 20 |
| 6 hours post-dose, moderate pain | 2 |
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).
| participants | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Onset of perceptible pain relief, no pain relief | 1 |
| Onset of perceptible pain relief, a little relief | 16 |
| Onset of perceptible pain relief, moderate relief | 9 |
| Onset of perceptible pain relief, a lot of relief | 16 |
| Onset of perceptible pain relief, complete relief | 4 |
| 3 hours post-dose, no pain relief | 2 |
| 3 hours post-dose, a little relief | 3 |
| 3 hours post-dose, moderate relief | 12 |
| 3 hours post-dose, a lot of relief | 17 |
| 3 hours post-dose, complete relief | 12 |
| 6 hours post-dose, no pain relief | 1 |
| 6 hours post-dose, a little relief | 2 |
| 6 hours post-dose, moderate relief | 1 |
| 6 hours post-dose, a lot of relief | 18 |
| 6 hours post-dose, complete relief | 24 |
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.
| ng/ml | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| 0 hour | 5.17 ± 1.55 |
| Onset of perceptible pain relief | 56.10 ± 37.61 |
| 3 hours post-dose | 176.34 ± 48.68 |
| 6 hours post-dose | 187.98 ± 67.03 |
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.
| participants | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Patients with at least one TEAE | 23 |
| Patients with at least one severe TEAE | 5 |
| Patients with at least one SAE | 0 |
| Patients with at least 1 possibly drug related AE | 23 |
| Patients with at least one TEAE requiring therapy | 3 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tramadol Contramid® Once-A-Day (OAD) | — | 0/47 (0%) | 23/47 (48.9%) |
| Event | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| SomnolenceNervous system disorders | 14/47 |
| DizzinessNervous system disorders | 8/47 |
| NauseaGastrointestinal disorders | 8/47 |
| Vomiting NOS (Not Otherwise Specified)Gastrointestinal disorders | 5/47 |
| Headache NOS (Not Otherwise Specified)Nervous system disorders | 4/47 |
| Dry mouthGastrointestinal disorders | 3/47 |
| Bradychardia NOS (Not Otherwise Specified)Cardiac disorders | 2/47 |
| Sweating increasedSkin and subcutaneous tissue disorders | 2/47 |
| SyncopeNervous system disorders | 1/47 |
| Age, Categorical(Participants) | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 21 |
| Age Continuous(years) | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Mean | 61.2 ± 10.2 |
| Sex: Female, Male(Participants) | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Female | 37 |
| Male | 10 |
| Region of Enrollment(participants) | Tramadol Contramid® Once-A-Day (OAD) |
|---|---|
| Romania | 47 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Labopharm Inc.