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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00640042
First received: March 13, 2008
Last updated: June 6, 2012
Last verified: June 2012
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.


Enrollment: 1570
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other Name: AVINZA

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 385 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Sherry Siegel, MD King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  More Information

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

Responsible Party: Pfizer
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 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
pain
opioid
abuse
moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 15, 2014