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

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

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

Period: 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
Other	7

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

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
ALO-01	No text entered.

Serious Adverse Events

	ALO-01
Total, serious adverse events
# participants affected / at risk	33/465 (7.10%)
Cardiac disorders
Acute myocardial infarction ^† # participants affected / at risk # events	1/465 (0.22%) 1
Angina pectoris ^† # participants affected / at risk # events	1/465 (0.22%) 1
Cardiac failure congestive ^† # participants affected / at risk # events	1/465 (0.22%) 1
Coronary artery disease ^† # participants affected / at risk # events	1/465 (0.22%) 1
Gastrointestinal disorders
Colitis ^† # participants affected / at risk # events	2/465 (0.43%) 2
Diarrhoea ^† # participants affected / at risk # events	1/465 (0.22%) 1
Gastrointestinal inflammation ^† # participants affected / at risk # events	1/465 (0.22%) 1
Pancreatitis ^† # participants affected / at risk # events	1/465 (0.22%) 1
Vomiting ^† # participants affected / at risk # events	1/465 (0.22%) 1
General disorders
Chest pain ^† # participants affected / at risk # events	2/465 (0.43%) 2
Pyrexia ^† # participants affected / at risk # events	1/465 (0.22%) 1
Hepatobiliary disorders
Cholelithiasis ^† # participants affected / at risk # events	1/465 (0.22%) 1
Infections and infestations
Arthritis bacterial ^† # participants affected / at risk # events	2/465 (0.43%) 2
Pyelonephritis acute ^† # participants affected / at risk # events	1/465 (0.22%) 1
Injury, poisoning and procedural complications
Ankle fracture ^† # participants affected / at risk # events	1/465 (0.22%) 1
Overdose (insulin) ^† # participants affected / at risk # events	1/465 (0.22%) 1
Metabolism and nutrition disorders
Diabetes mellitus inadequate control ^† # participants affected / at risk # events	1/465 (0.22%) 1
Hypoglycaemia ^† # participants affected / at risk # events	1/465 (0.22%) 1
Ketosis ^† # participants affected / at risk # events	1/465 (0.22%) 1
Musculoskeletal and connective tissue disorders
Arthralgia ^† # participants affected / at risk # events	1/465 (0.22%) 1
Invertebral disc protrusion ^† # participants affected / at risk # events	1/465 (0.22%) 1
Osteoarthritis ^† # participants affected / at risk # events	2/465 (0.43%) 2
Rheumatoid arthritis ^† # participants affected / at risk # events	1/465 (0.22%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I ^† # participants affected / at risk # events	1/465 (0.22%) 1
Nervous system disorders
Carotid artery stenosis ^† # participants affected / at risk # events	1/465 (0.22%) 1
Lumbar radiculopathy ^† # participants affected / at risk # events	1/465 (0.22%) 2
Transient ischaemic attack ^† # participants affected / at risk # events	1/465 (0.22%) 1
Psychiatric disorders
Conversion disorder ^† # participants affected / at risk # events	1/465 (0.22%) 1
Somatoform disorder ^† # participants affected / at risk # events	1/465 (0.22%) 1
Suicidal ideation ^† # participants affected / at risk # events	1/465 (0.22%) 1
Surgical and medical procedures
Appendicectomy ^† # participants affected / at risk # events	1/465 (0.22%) 1
Hip surgery ^† # participants affected / at risk # events	1/465 (0.22%) 1
Vascular disorders
Deep vein thrombosis ^† # participants affected / at risk # events	2/465 (0.43%) 2
Peripheral vascular disorder ^† # participants affected / at risk # events	1/465 (0.22%) 1

^†	Indicates events were collected by systematic assessment.

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, Inc. ( Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development )
Study ID Numbers:	ALO-KNT-302
Study First Received:	December 21, 2006
Results First Received:	September 11, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00415597 History of Changes
Health Authority:	United States: Food and Drug Administration