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 Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acute Low Back Pain
Intervention:	Drug: Tramadol Contramid® OAD 200mg

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tramadol Contramid® Once-A-Day (OAD)	Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Participant Flow: Overall Study

	Tramadol Contramid® Once-A-Day (OAD)
STARTED	47
COMPLETED	40
NOT COMPLETED	7
Adverse Event	3
Withdrawal by Subject	4

Baseline Characteristics

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Reporting Groups

	Description
Tramadol Contramid® Once-A-Day (OAD)	Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Baseline Measures

	Tramadol Contramid® Once-A-Day (OAD)
Number of Participants [units: participants]	47
Age [units: participants]
<=18 years	0
Between 18 and 65 years	26
>=65 years	21
Age [units: years] Mean ± Standard Deviation	61.2 ± 10.2
Gender [units: participants]
Female	37
Male	10
Region of Enrollment [units: participants]
Romania	47

Outcome Measures

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1. Primary:

Time to Onset of Perceptible Pain Relief [ Time Frame: 6 hours ]

Measure Type	Primary
Measure Title	Time to Onset of Perceptible Pain Relief
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Tramadol Contramid® Once-A-Day (OAD)	Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Measured Values

	Tramadol Contramid® Once-A-Day (OAD)
Number of Participants Analyzed [units: participants]	46
Time to Onset of Perceptible Pain Relief [units: minutes] Median ( 95% Confidence Interval )	47 ( 40 to 51 )

No statistical analysis provided for Time to Onset of Perceptible Pain Relief

2. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Tramadol Contramid® Once-A-Day (OAD)	Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Measured Values

	Tramadol Contramid® Once-A-Day (OAD)
Number of Participants Analyzed [units: participants]	46
Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose [units: participants]
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

No statistical analysis provided for Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose

3. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Tramadol Contramid® Once-A-Day (OAD)	Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Measured Values

	Tramadol Contramid® Once-A-Day (OAD)
Number of Participants Analyzed [units: participants]	46
Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose [units: participants]
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

No statistical analysis provided for Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose

4. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Tramadol Contramid® Once-A-Day (OAD)	Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Measured Values

	Tramadol Contramid® Once-A-Day (OAD)
Number of Participants Analyzed [units: participants]	46
Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose [units: ng/ml] Mean ± Standard Deviation
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

No statistical analysis provided for Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose

5. Secondary:

Number of Participants With Adverse Events [ Time Frame: 6 hours ]

Measure Type	Secondary
Measure Title	Number of Participants With Adverse Events
Measure 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
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population: includes all patients who received the dose of the study medication.

Reporting Groups

	Description
Tramadol Contramid® Once-A-Day (OAD)	Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Measured Values

	Tramadol Contramid® Once-A-Day (OAD)
Number of Participants Analyzed [units: participants]	47
Number of Participants With Adverse Events [units: participants]
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

No statistical analysis provided for Number of Participants With Adverse Events

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
phone: 1 450 686 1017

Publications of Results:

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.

Responsible Party:	Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00952068 History of Changes
Other Study ID Numbers:	MDT2-002
Study First Received:	April 16, 2009
Results First Received:	April 16, 2009
Last Updated:	April 25, 2012
Health Authority:	Romania: National Medicines Agency