A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

This study has been completed.

Study NCT00420992 Information provided by Alpharma Inc.

First Received: January 10, 2007 Last Updated: October 28, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Conditions:	Osteoarthritis Chronic Pain
Interventions:	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) 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
ALO-01	No text entered.
Placebo	No text entered.

Participant Flow for 2 periods

Period: Titration Phase

	ALO-01	Placebo
STARTED	547^[1]	0
COMPLETED	344	0
NOT COMPLETED	203	0

[1]	All patients received ALO-01 during open-label titration phase

Period: Maintenance Phase

	ALO-01	Placebo
STARTED	171	173
COMPLETED	110	98
NOT COMPLETED	61	75

Baseline Characteristics

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Reporting Groups

	Description
ALO-01	No text entered.
Placebo	No text entered.

Baseline Measures

	ALO-01	Placebo	Total
Number of Participants [units: participants]	171	173	344
Age [units: years] Mean ± Standard Deviation	54.2 ± 11.62	54.7 ± 12.92	54.4 ± 12.27
Gender [units: participants]
Female	106	95	201
Male	65	78	143

Outcome Measures

1. Primary:

Mean Change in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) [ randomization to 12 weeks following randomization ]

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Measure Type	Primary
Measure Title	Mean Change in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
Measure Description	Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
Time Frame	randomization to 12 weeks following randomization
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.
intent to treat (ITT)

Reporting Groups

	Description
ALO-01	No text entered.
Placebo	No text entered.

Measured Values

	ALO-01	Placebo
Number of Participants Analyzed [units: participants]	170	173
Mean Change in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) [units: units on scale (change from baseline)] Mean ± Standard Deviation	-0.2 ± 1.94	0.3 ± 2.05

Statistical Analysis 1 for Mean Change in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0445

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model included treatment as factor and baseline pain score as covariate.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.

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: 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 90 days from the time submitted to the Sponsor for review. Sponsor may request a delay in publication to allow the filing of patent applications before publication or release. The sponsor can require deletion of Confidential Information or request correction of inaccuracies.

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: Vice President, Clinical Development
Organization: King Pharmaceuticals Research and Development, Inc.
phone: 919-653-7001

No publications provided

Responsible Party:	King Pharmaceuticals Research and Development ( Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development )
Study ID Numbers:	ALO-KNT-301
Study First Received:	January 10, 2007
Results First Received:	September 11, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00420992 History of Changes
Health Authority:	United States: Food and Drug Administration