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Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza (ACCESS 2008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640042
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : February 15, 2010
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 13, 2008
First Posted Date  ICMJE March 20, 2008
Results First Submitted Date  ICMJE November 30, 2009
Results First Posted Date  ICMJE February 15, 2010
Last Update Posted Date June 11, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • 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) ]
    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
  • 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) ]
    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
  • 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) ]
    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
  • Number of Subjects With Treatment Emergent Adverse Events [ Time Frame: Up to 4 months ]
    Adverse events that occur or worsen after the first dose of Avinza
  • Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) [ Time Frame: 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.
  • Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • 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 ]
  • The incidence and characterization of AEs [ Time Frame: 3-4 months ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • 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 ]
    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.
  • 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 ]
    The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
  • 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 ]
    The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
Official Title  ICMJE 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
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE 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.
Other Name: AVINZA
Study Arms  ICMJE Experimental: 1
Intervention: Drug: morphine sulfate extended release capsules
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2010)
1570
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2008)
2000
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640042
Other Study ID Numbers  ICMJE K284-07-4001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sherry Siegel, MD King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP