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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Adamsville, Alabama, 35005 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00640042
Pfizer
Completed
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza

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

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
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
Experimental: 1
Intervention: Drug: morphine sulfate extended release capsules


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1570
December 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00640042
K284-07-4001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Sherry Siegel, MD King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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