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Study 19 of 2400 for search of: | United States, Kentucky |
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Sponsored by: |
King Pharmaceuticals |
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Information provided by: | King Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00640042 |
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 |
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Pain |
Drug: morphine sulfate extended release capsules |
Phase IV |
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 |
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 |
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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.
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A patient who meets ANY of the following exclusion criteria will not be enrolled:
Study Director: | Sherry Siegel, MD | King Pharmaceuticals |
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 |
pain opioid abuse moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time |
Morphine Pain |
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 |