Trial · NCT00640042
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
NCT00640042, Phase 4, Completed, Pfizer; results first posted 2010-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza. Trials, record NCT00640042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00640042
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
- NCT number
- NCT00640042
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,570 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pain
- Interventions
- morphine sulfate extended release capsules
- First posted
- 2008-03-20
- Last updated
- 2012-06-11
- Results first posted
- 2010-02-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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 |
| Primary | 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 |
| Primary | Number of Subjects With Treatment Emergent Adverse Events | Up to 4 months | Adverse events that occur or worsen after the first dose of Avinza |
| Primary | 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. |
| Primary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) | Baseline (Week 0) to Visit 3 (Week 6) | Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6) | units on scale | MEAN |
| PRIMARY | Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) | Baseline (Week 0) to Visit 4 (Week 10) | Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10) | units on scale | MEAN |
| PRIMARY | 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) | Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study) | units on scale | MEAN |
| PRIMARY | Number of Subjects With Treatment Emergent Adverse Events | Up to 4 months | participants | NUMBER | |
| PRIMARY | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Visit 3 (Week 6) | Number of subjects with risk level assessment at Visit 3 (Week 6) | participants | NUMBER |
| PRIMARY | Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Visit 4 (Week 10) | Number of subjects with risk level assessment at Visit 4 (Week 10) | participants | NUMBER |
| SECONDARY | 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 | Number of subjects with risk level assessment at Visit 4 (Week 10) | cases | NUMBER |
| SECONDARY | Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. | 3 months post study | Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator. | investigators | NUMBER |
| SECONDARY | 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 | Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator. | investigators | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) | Avinza | -1.6 | Standard Deviation 2.27 | units on scale | |
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) | Avinza | -1.7 | Standard Deviation 2.24 | units on scale | |
| Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) | Avinza | -1.1 | Standard Deviation 2.31 | units on scale | |
| Number of Subjects With Treatment Emergent Adverse Events | Avinza | 707 | participants | ||
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Avinza | Low risk | 433 | participants | |
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Avinza | Moderate risk | 325 | participants | |
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Avinza | High risk | 8 | participants | |
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) | Avinza | Missing | 3 | participants | |
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Avinza | Low risk | 355 | participants | |
| Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) | Avinza | Moderate risk | 267 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrollment | STARTED | Avinza | 1,570 | |
| Enrollment | COMPLETED | Avinza | 1,487 | |
| Enrollment | NOT COMPLETED | Avinza | 83 | |
| Treatment | STARTED | Avinza | 1,487 | |
| Treatment | COMPLETED | Avinza | 561 | |
| Treatment | NOT COMPLETED | Avinza | 926 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Avinza | 203 | 1,487 | 218 |
| other | Nausea | Gastrointestinal disorders | Avinza | 162 | 1,487 | 170 |
| other | Vomiting | Gastrointestinal disorders | Avinza | 78 | 1,487 | 80 |
| other | Somnolence | Nervous system disorders | Avinza | 79 | 1,487 | 88 |
| serious | Anaemia | Blood and lymphatic system disorders | Avinza | 2 | 1,487 | 2 |
| serious | Neutropenia | Blood and lymphatic system disorders | Avinza | 1 | 1,487 | 2 |
| serious | Cardiac failure congestive | Cardiac disorders | Avinza | 4 | 1,487 | 4 |
| serious | Myocardial infarction | Cardiac disorders | Avinza | 2 | 1,487 | 2 |
| serious | Acute myocardial infarction | Cardiac disorders | Avinza | 1 | 1,487 | 1 |
| serious | Cor pulmonale | Cardiac disorders | Avinza | 1 | 1,487 | 1 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avinza | ||
| Total, other adverse events | Avinza | 394 | 1,487 |
| Total, serious adverse events | Avinza | 60 | 1,487 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00640042
GET https://conductscience.org/api/trials/v1/NCT00640042/events?page=2