A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Labopharm Inc.

ClinicalTrials.gov Identifier:

NCT00832416

First received: January 29, 2009

Last updated: April 25, 2012

Last verified: April 2012

History of Changes

Results First Received: April 8, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Pain Osteoarthritis, Knee
Interventions:	Drug: Tramadol Once A Day Drug: Placebo

Participant Flow

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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
1: Tramadol Once A Day 100mg	No text entered.
2: Tramadol Once A Day 200mg	No text entered.
3: Tramadol Once A Day 300mg	No text entered.
4: Placebo	No text entered.

Participant Flow: Overall Study

	1: Tramadol Once A Day 100mg	2: Tramadol Once A Day 200mg	3: Tramadol Once A Day 300mg	4: Placebo
STARTED	110	113	115	227
COMPLETED	64	60	54	144
NOT COMPLETED	46	53	61	83
Lack of Efficacy	17	15	13	52
Withdrawal by Subject	5	7	2	10
Physician Decision	2	12	5	10
Administrative	0	0	0	1
Adverse Event	21	19	41	10
Death	1	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
1: Tramadol Once A Day 100mg	No text entered.
2: Tramadol Once A Day 200mg	No text entered.
3: Tramadol Once A Day 300mg	No text entered.
4: Placebo	No text entered.
Total	Total of all reporting groups

Baseline Measures

	1: Tramadol Once A Day 100mg	2: Tramadol Once A Day 200mg	3: Tramadol Once A Day 300mg	4: Placebo	Total
Number of Participants [units: participants]	110	113	115	227	565
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	69	77	66	139	351
>=65 years	41	36	49	88	214
Age [units: years] Mean ± Standard Deviation	59.8 ± 9.0	59.8 ± 8.4	61.0 ± 9.6	60.6 ± 9.6	60.4 ± 9.3
Gender [units: participants]
Female	65	64	72	140	341
Male	45	49	43	87	224

Outcome Measures

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1. Primary:

Patient Global Rating of Pain for the Study Period (12 Weeks) [ Time Frame: 12 weeks ]

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2. Primary:

Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) [ Time Frame: Baseline to week 12 ]

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3. Primary:

Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) [ Time Frame: Baseline to week 12 ]

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4. Secondary:

Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) [ Time Frame: Week 0, week 3, week 6 ]

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5. Secondary:

Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) [ Time Frame: Week 0, week 3, week 6 ]

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6. Secondary:

Multiple Dose Effect Using 24-hour VAS Pain Questionnaire [ Time Frame: 12 weeks ]

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7. Secondary:

Investigator Global Rating of Pain Relief [ Time Frame: 12 weeks ]

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8. Secondary:

Percentage of Participants Who Dropped Out From Trial by Dropout Reason [ Time Frame: 12 weeks ]

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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

No publications provided

Responsible Party:	Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00832416 History of Changes
Other Study ID Numbers:	MDT3-002
Study First Received:	January 29, 2009
Results First Received:	April 8, 2009
Last Updated:	April 25, 2012
Health Authority:	United States: Food and Drug Administration

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