An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in 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:

NCT00833911

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:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Osteoarthritis, Knee
Intervention:	Drug: Tramadol Once A Day

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
300 mg Tramadol HCl OAD	No text entered.

Participant Flow for 3 periods

Period 1: Titration

	300 mg Tramadol HCl OAD
STARTED	392
COMPLETED	371
NOT COMPLETED	21
Adverse Event	18
Withdrawal by Subject	3

Period 2: Maintenance Phase I

	300 mg Tramadol HCl OAD
STARTED	371
COMPLETED	273
NOT COMPLETED	98
Adverse Event	73
Withdrawal by Subject	11
Physician Decision	10
Lack of Efficacy	4

Period 3: Maintenance Phase II

	300 mg Tramadol HCl OAD
STARTED	176 ^[1]
COMPLETED	166
NOT COMPLETED	10
Adverse Event	6
Physician Decision	2
Withdrawal by Subject	1
Lack of Efficacy	1

[1]	97 patients chose not to continue into Maintenance Phase II

Baseline Characteristics

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Reporting Groups

	Description
300 mg Tramadol HCl OAD	No text entered.

Baseline Measures

	300 mg Tramadol HCl OAD
Number of Participants [units: participants]	392
Age [units: participants]
<=18 years	0
Between 18 and 65 years	229
>=65 years	163
Age [units: years] Mean ± Standard Deviation	61.4 ± 8.5
Gender [units: participants]
Female	333
Male	59

Outcome Measures

1. Primary:

Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation [ Time Frame: 6 months and 12 months ]

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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

Publications of Results:

Mongin G. Tramadol extended-release formulations in the management of pain due to osteoarthritis. Expert Rev Neurother. 2007 Dec;7(12):1775-84. Review.

Responsible Party:	Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00833911 History of Changes
Other Study ID Numbers:	MDT3-004
Study First Received:	January 29, 2009
Results First Received:	April 8, 2009
Last Updated:	April 25, 2012
Health Authority:	Romania: National Medicines Agency

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