Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pain
Intervention:	Drug: morphine sulfate extended release capsules

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
Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Description

Avinza

Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Participant Flow for 2 periods

Period 1: Enrollment

	Avinza
STARTED	1570 ^[1]
COMPLETED	1487 ^[2]
NOT COMPLETED	83
Did not receive study drug	83

[1]	Number of patients with evidence of prescription card receipt
[2]	Number of patients with evidence of study drug receipt

Period 2: Treatment

	Avinza
STARTED	1487
COMPLETED	561
NOT COMPLETED	926

Baseline Characteristics

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Reporting Groups

	Description
Avinza	Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Description

Avinza

Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.

Baseline Measures

	Avinza
Number of Participants [units: participants]	1487
Age [units: years] Mean ± Standard Deviation	52.7 ± 13.62
Gender, Customized [units: participants]
Female	839
Male	630
Missing	18
Risk level for opioid misuse or abuse ^[1] [units: participants]
Low	694
Moderate	767
High	19
Missing	7

[1]	Investigator determined classification of potential risk based on assessment of urine drug tests and patient history and questionnaires

Outcome Measures

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1. Primary:

Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) [ Time Frame: Baseline (Week 0) to Visit 3 (Week 6) ]

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2. Primary:

Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) [ Time Frame: Baseline (Week 0) to Visit 4 (Week 10) ]

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3. Primary:

Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) [ Time Frame: Baseline (Week 0) to Visit 5 (Week 14 / End of Study) ]

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4. Primary:

Number of Subjects With Treatment Emergent Adverse Events [ Time Frame: Up to 4 months ]

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5. Primary:

Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) [ Time Frame: Visit 3 (Week 6) ]

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6. Primary:

Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) [ Time Frame: Visit 4 (Week 10) ]

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7. Secondary:

Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. [ Time Frame: Up to 4 months ]

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8. Secondary:

Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. [ Time Frame: 3 months post study ]

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9. Secondary:

Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion. [ Time Frame: 6 months post study ]

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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: Results may only be published through Sponsor.

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: Professional Information Services
Organization: King Pharmaceuticals, Inc.
phone: 1-800-776-3637

Publications:

Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.

Joranson DE, Berger JW. Regulatory issues in pain management. J Am Pharm Assoc (Wash). 2000 Sep-Oct;40(5 Suppl 1):S60-1.

Caldwell JR, Rapoport RJ, Davis JC, Offenberg HL, Marker HW, Roth SH, Yuan W, Eliot L, Babul N, Lynch PM. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002 Apr;23(4):278-91.

Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain. J Opioid Manag. 2006 May-Jun;2(3):155-66. Erratum in: J Opioid Manag. 2006 Sep-Oct;2(5):276.

Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial. J Opioid Manag. 2006 Nov-Dec;2(6):325-8, 331-3.

Rosenthal M, Moore P, Groves E, Iwan T, Schlosser LG, Dziewanowska Z, Negro-Vilar A. Sleep improves when patients with chronic OA pain are managed with morning dosing of once a day extended-release morphine sulfate (AVINZA): findings from a pilot study. J Opioid Manag. 2007 May-Jun;3(3):145-54.

Katz NP, Adams EH, Chilcoat H, Colucci RD, Comer SD, Goliber P, Grudzinskas C, Jasinski D, Lande SD, Passik SD, Schnoll SH, Sellers E, Travers D, Weiss R. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007 Oct;23(8):648-60. Review.

Ives TJ, Chelminski PR, Hammett-Stabler CA, Malone RM, Perhac JS, Potisek NM, Shilliday BB, DeWalt DA, Pignone MP. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006 Apr 4;6:46.

Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005 Mar-Apr;6(2):107-12.

Responsible Party:	Linda Wase, MD, Executive Vice President Medical Affairs, King Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00640042 History of Changes
Other Study ID Numbers:	K284-07-4001
Study First Received:	March 13, 2008
Results First Received:	November 30, 2009
Last Updated:	June 29, 2010
Health Authority:	United States: Institutional Review Board