Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza - Full Text View

Sponsored by:	King Pharmaceuticals
Information provided by:	King Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00640042

Purpose

The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.

Condition	Intervention	Phase
Pain	Drug: morphine sulfate extended release capsules	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	AVINZA Control of Chronic Pain, Effectiveness and Safety Study (ACCESS 2008) A Multi-Center Study to Evaluate the Effectiveness and Tolerability of AVINZA for Chronic Moderate-Severe Pain: A Focus on Risk Minimization Assessment, Intervention and Outcomes

Further study details as provided by King Pharmaceuticals:

Primary Outcome Measures:

Difference from baseline in the average pain score at each subsequent visit based on a numerical rating scale of pain [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
The incidence and characterization of AEs [ Time Frame: 3-4 months ] [ Designated as safety issue: Yes ]
The number of patients at each level of risk for opioid misuse or abuse during each visit as determined by the use of study tools. [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of investigators with greater than or equal to 75% patient compliance with major components of the universal precautions approach to pain management as defined by the protocol. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Difference from baseline in the activities of daily living score at each subsequent visit based on a numerical rating scale [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: morphine sulfate extended release capsules 30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.

Detailed Description:

Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia.

Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.

This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is an adult (greater than or equal to 21 years old
Patient has chronic (greater than or equal to 3 months) moderate-severe pain who, at the discretion of the Investigator, requires an around-the-clock opioid for optimal analgesia. Patients may be opioid naïve (not currently on an opioid) or opioid tolerant. Opioid naïve patients with a pain score of greater than or equal to 4 on an 11-point NRS (numerical rating scale. OR Opioid tolerant patients experiencing suboptimal response (i.e. pain score of greater than or equal to 4) or unacceptable side effects to sustained release opioids or short-acting opioids.
Patient is able to read and understand English and comply with protocol requirements.

Exclusion Criteria:

A patient who meets ANY of the following exclusion criteria will not be enrolled:

Hypersensitivity to morphine, morphine salts, or any components of AVINZA
Respiratory depression (slowed breathing)
Acute or severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD)
Currently has or is suspected of having paralytic ileus
Requires a daily dose of AVINZA greater than 1600mg/day
Patient is abusing alcohol
Pregnancy or breast feeding
Currently taking AVINZA
Patient unwilling to sign the Treatment Agreement
Life expectancy is less than 2 months
Migraine as the primary pain score
Patient resides in a hospital or nursing home
Patient has had more than 2 surgeries for low back pain
Patient is anticipated to require major surgery or steroid injections for chronic pain over the next 12 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640042

Show 386 Study Locations

Sponsors and Collaborators

King Pharmaceuticals

Investigators

Study Director:

Sherry Siegel, MD

King Pharmaceuticals

More Information

Publications:

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:	King Pharmaceuticals, Inc. ( Linda Wase, MD, Executive Vice President Medical Affairs )
Study ID Numbers:	K284-07-4001
Study First Received:	March 13, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00640042
Health Authority:	United States: Institutional Review Board

Keywords provided by King Pharmaceuticals:

pain
opioid
abuse
moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time

Study placed in the following topic categories:

Morphine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009