Trial Outcomes & Findings for 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 (NCT NCT00952068)

NCT ID: NCT00952068

Last Updated: 2012-04-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2012-04-30

Participant Flow

Participant milestones

Measure	Tramadol Contramid® Once-A-Day (OAD) Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Study STARTED	47
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Tramadol Contramid® Once-A-Day (OAD) Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tramadol Contramid® Once-A-Day (OAD) n=47 Participants Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age Continuous	61.2 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Romania	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.

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.

Outcome measures

Measure	Tramadol Contramid® Once-A-Day (OAD) n=46 Participants Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Time to Onset of Perceptible Pain Relief	47 minutes Interval 40.0 to 51.0

SECONDARY outcome

Timeframe: Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief

Population: Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.

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).

Outcome measures

Measure	Tramadol Contramid® Once-A-Day (OAD) n=46 Participants Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Baseline, moderate pain	34 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Baseline, severe pain	12 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, no pain	4 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, mild pain	23 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, moderate pain	19 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, no pain	12 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, mild pain	25 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, moderate pain	9 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, no pain	24 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, mild pain	20 participants
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, moderate pain	2 participants

SECONDARY outcome

Timeframe: 3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief

Population: Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.

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).

Outcome measures

Measure	Tramadol Contramid® Once-A-Day (OAD) n=46 Participants Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, complete relief	24 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, no pain relief	1 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, a little relief	16 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, moderate relief	9 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, a lot of relief	16 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose Onset of perceptible pain relief, complete relief	4 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, no pain relief	2 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, a little relief	3 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, moderate relief	12 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, a lot of relief	17 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 3 hours post-dose, complete relief	12 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, no pain relief	1 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, a little relief	2 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, moderate relief	1 participants
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose 6 hours post-dose, a lot of relief	18 participants

SECONDARY outcome

Timeframe: Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose

Population: Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.

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.

Outcome measures

Measure	Tramadol Contramid® Once-A-Day (OAD) n=46 Participants Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose 0 hour	5.17 ng/ml Standard Deviation 1.55
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose Onset of perceptible pain relief	56.10 ng/ml Standard Deviation 37.61
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose 3 hours post-dose	176.34 ng/ml Standard Deviation 48.68
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose 6 hours post-dose	187.98 ng/ml Standard Deviation 67.03

SECONDARY outcome

Timeframe: 6 hours

Population: Safety population: includes all patients who received the dose of the study medication.

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.

Outcome measures

Measure	Tramadol Contramid® Once-A-Day (OAD) n=47 Participants Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Number of Participants With Adverse Events Patients with at least one TEAE	23 participants
Number of Participants With Adverse Events Patients with at least one severe TEAE	5 participants
Number of Participants With Adverse Events Patients with at least one SAE	0 participants
Number of Participants With Adverse Events Patients with at least 1 possibly drug related AE	23 participants
Number of Participants With Adverse Events Patients with at least one TEAE requiring therapy	3 participants

Adverse Events

Tramadol Contramid® Once-A-Day (OAD)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tramadol Contramid® Once-A-Day (OAD) n=47 participants at risk Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Nervous system disorders Somnolence	29.8% 14/47 • Number of events 15
Nervous system disorders Dizziness	17.0% 8/47 • Number of events 12
Gastrointestinal disorders Nausea	17.0% 8/47 • Number of events 12
Gastrointestinal disorders Vomiting NOS (Not Otherwise Specified)	10.6% 5/47 • Number of events 10
Nervous system disorders Headache NOS (Not Otherwise Specified)	8.5% 4/47 • Number of events 4
Gastrointestinal disorders Dry mouth	6.4% 3/47 • Number of events 4
Cardiac disorders Bradychardia NOS (Not Otherwise Specified)	4.3% 2/47 • Number of events 2
Skin and subcutaneous tissue disorders Sweating increased	4.3% 2/47 • Number of events 2
Nervous system disorders Syncope	2.1% 1/47 • Number of events 1

Additional Information

Director of Regulatory Affairs

Labopharm Inc.

Phone: 1 450 686 1017

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to submitting results communications, the investigator shall allow Labopharm at least 30 days to review the proposed communication. If the proposed publication/disclosure risks Labopharm's ability to patent any invention related to the study, the publication or disclosure will be modified or delayed to allow Labopharm to seek patent protection. This statement does not give Labopharm any editorial rights other than to restrict the disclosure of Labopharm's confidential information.
• Publication restrictions are in place

Restriction type: OTHER