Pain
Conditions
Keywords
pain, opioid, abuse, moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time
Brief 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.
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.
Interventions
DRUGmorphine 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.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Visit 4 (Week 10) | 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. |
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) | Baseline (Week 0) to Visit 5 (Week 14 / End of Study) | 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 | Up to 4 months | 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) | Visit 3 (Week 6) | 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. |
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) | Baseline (Week 0) to Visit 3 (Week 6) | 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) | Baseline (Week 0) to Visit 4 (Week 10) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. | 3 months post study | 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. | 6 months post study | 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 Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. | Up to 4 months | 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. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avinza Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day. | 1,487 |
| Total | 1,487 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrollment | Did not receive study drug | 83 |
Baseline characteristics
| Characteristic | Avinza |
|---|---|
| Age Continuous | 52.7 years STANDARD_DEVIATION 13.62 |
| Risk level for opioid misuse or abuse High | 19 participants |
| Risk level for opioid misuse or abuse Low | 694 participants |
| Risk level for opioid misuse or abuse Missing | 7 participants |
| Risk level for opioid misuse or abuse Moderate | 767 participants |
| Sex/Gender, Customized Female | 839 participants |
| Sex/Gender, Customized Male | 630 participants |
| Sex/Gender, Customized Missing | 18 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 394 / 1,487 |
| serious Total, serious adverse events | 60 / 1,487 |
Outcome results
Primary
Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)
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
Time frame: Baseline (Week 0) to Visit 3 (Week 6)
Population: Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avinza | Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) | -1.6 units on scale | Standard Deviation 2.27 |
Primary
Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)
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
Time frame: Baseline (Week 0) to Visit 4 (Week 10)
Population: Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avinza | Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) | -1.7 units on scale | Standard Deviation 2.24 |
Primary
Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)
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
Time frame: Baseline (Week 0) to Visit 5 (Week 14 / End of Study)
Population: Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avinza | Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) | -1.1 units on scale | Standard Deviation 2.31 |
Primary
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
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.
Time frame: Visit 3 (Week 6)
Population: Number of subjects with risk level assessment at Visit 3 (Week 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Low risk | 433 participants |
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Moderate risk | 325 participants |
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | High risk | 8 participants |
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Missing | 3 participants |
Primary
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
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.
Time frame: Visit 4 (Week 10)
Population: Number of subjects with risk level assessment at Visit 4 (Week 10)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | High risk | 7 participants |
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Low risk | 355 participants |
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Moderate risk | 267 participants |
| Avinza | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Missing | 4 participants |
Primary
Number of Subjects With Treatment Emergent Adverse Events
Adverse events that occur or worsen after the first dose of Avinza
Time frame: Up to 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avinza | Number of Subjects With Treatment Emergent Adverse Events | 707 participants |
Secondary
Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.
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.
Time frame: Up to 4 months
Population: Number of subjects with risk level assessment at Visit 4 (Week 10)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avinza | Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. | Satisfied / Very Satisfied | 1010 cases |
| Avinza | Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. | Neutral | 278 cases |
| Avinza | Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. | Dissatisfied / Very dissatisfied | 56 cases |
| Avinza | Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. | Missing | 143 cases |
Secondary
Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.
The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
Time frame: 3 months post study
Population: Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avinza | Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. | Use of at least one tool | 206 investigators |
| Avinza | Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. | Use of no tools | 13 investigators |
Secondary
Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.
The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
Time frame: 6 months post study
Population: Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avinza | Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion. | Use of at least one tool | 156 investigators |
| Avinza | Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion. | Use of no tools | 13 investigators |