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

Last updated on March 14, 2019

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.
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- 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.
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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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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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