Phase 4
Completed N=1,570
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
Source: ClinicalTrials.gov NCT00640042 ↗Enrolled (actual)
1,570
Serious AEs
4.0%
Results posted
Feb 2010
Primary outcomePrimary: Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) — -1.6 units on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) |
-1.6 | — |
| PRIMARY Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) |
-1.7 | — |
| PRIMARY Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) |
-1.1 | — |
| PRIMARY Number of Subjects With Treatment Emergent Adverse Events |
707 | — |
| PRIMARY Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) |
433; 325; 8; 3 | — |
| PRIMARY Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) |
355; 267; 7; 4 | — |
| SECONDARY Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. |
1010; 278; 56; 143 | — |
| SECONDARY Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. |
206; 13 | — |
| SECONDARY Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion. |
156; 13 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00640042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.