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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