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 Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

First Received on December 21, 2006. Last Updated on December 7, 2009 History of Changes

Results First Received: September 11, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pain
Intervention:	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)

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.

Participant Flow for 2 periods

Period 1: Enrollment

	ALO-01
STARTED	467
COMPLETED	465
NOT COMPLETED	2
Withdrawal by Subject	1
Protocol Violation	1

Period 2: Treatment

	ALO-01
STARTED	465
COMPLETED	160
NOT COMPLETED	305
Adverse Event	110
Lack of Efficacy	39
Protocol Violation	67
Physician Decision	3
Withdrawal by Subject	51
Lost to Follow-up	28
Drug Screen	2
Administrative	3
Sponsor Decision	1
Multiple Reasons	1

Baseline Characteristics

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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
Brief Pain Inventory (BPI) Average Pain ^[1] [units: Units on scale] Mean ± Standard Deviation	6.0 ± 1.67

[1]	All patients reporting a BPI average pain score (over last 24 hours: 0=no pain, 10=worst pain) at baseline

Outcome Measures

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1. Primary:

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

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2. Secondary:

Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 12 weeks ]

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3. Secondary:

Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 52 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: 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 by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Publications automatically indexed to this study:

Webster LR, Brewer R, Morris D, Cleveland JM, Setnik B. Opioid titration and conversion in patients receiving morphine sulfate and naltrexone hydrochloride extended release capsules. Postgrad Med. 2011 Sep;123(5):155-64.

Webster LR, Brewer R, Wang C, Sekora D, Johnson FK, Morris D, Stauffer J. Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain. J Pain Symptom Manage. 2010 Nov;40(5):734-46.

Responsible Party:	Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development, King Pharmaceuticals Research and Development, Inc.
ClinicalTrials.gov Identifier:	NCT00415597 History of Changes
Other Study ID Numbers:	ALO-KNT-302
Study First Received:	December 21, 2006
Results First Received:	September 11, 2009
Last Updated:	December 7, 2009
Health Authority:	United States: Food and Drug Administration