Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
CompletedPhase 4NCT00640042
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Drug: morphine sulfate extended release capsules
- Sponsor
- Pfizer
- Start date
- 2008-03
- Primary completion
- 2008-11
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Puerto Rico, United States
- Total sites listed
- 384
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00640042