Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

This study has been completed.

Study NCT00415597 Information provided by Alpharma Inc.

First Received: December 21, 2006 Last Updated: October 28, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition:	Pain
Intervention:	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)

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
ALO-01	No text entered.

Participant Flow for 2 periods

Period: Enrollment

Period: Treatment

Baseline Characteristics

Reporting Groups

	Description
ALO-01	No text entered.

Baseline Measures

	ALO-01
Number of Participants [units: participants]	465
Age [units: participants]
<=18 years	0
Between 18 and 65 years	417
>=65 years	48
Age [units: years] Mean ± Standard Deviation	51.7 ± 10.56
Gender [units: participants]
Female	245
Male	220

Outcome Measures

1. Primary:

Subjects With Treatment Emergent Adverse Events [ up to 12 months ]

Show Outcome Measure 1

2. Secondary:

Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ 12 weeks ]

Show Outcome Measure 2

3. Secondary:

Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ 52 weeks ]

Show Outcome Measure 3