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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: morphine sulfate extended release capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: morphine sulfate extended release capsules<br>* 30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.<br>* Other names: AVINZA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) | Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3 | Baseline (Week 0) to Visit 3 (Week 6) | 
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) | Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4 | Baseline (Week 0) to Visit 4 (Week 10) | 
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) | Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study | Baseline (Week 0) to Visit 5 (Week 14 / End of Study) | 
| Number of Subjects With Treatment Emergent Adverse Events | Adverse events that occur or worsen after the first dose of Avinza | Up to 4 months | 
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior. | Visit 3 (Week 6) | 
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Risk level was determined by the investigator using the subject's SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior. | Visit 4 (Week 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. | After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain. | Up to 4 months | 
| Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. | The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information. | 3 months post study | 
| Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion. | The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information. | 6 months post study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, opioid, abuse, moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time