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Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza (ACCESS 2008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640042
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : February 15, 2010
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: morphine sulfate extended release capsules
Enrollment 1570
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Avinza
Hide Arm/Group Description 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.
Period Title: Enrollment
Started 1570 [1]
Completed 1487 [2]
Not Completed 83
Reason Not Completed
Did not receive study drug             83
[1]
Number of patients with evidence of prescription card receipt
[2]
Number of patients with evidence of study drug receipt
Period Title: Treatment
Started 1487
Completed 561
Not Completed 926
Arm/Group Title Avinza
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1487
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1487 participants
52.7  (13.62)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1487 participants
Female 839
Male 630
Missing 18
Risk level for opioid misuse or abuse   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1487 participants
Low 694
Moderate 767
High 19
Missing 7
[1]
Measure Description: Investigator determined classification of potential risk based on assessment of urine drug tests and patient history and questionnaires
1.Primary Outcome
Title Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6)
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 755
Mean (Standard Deviation)
Unit of Measure: units on scale
-1.6  (2.27)
2.Primary Outcome
Title Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10)
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 622
Mean (Standard Deviation)
Unit of Measure: units on scale
-1.7  (2.24)
3.Primary Outcome
Title Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study)
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1105
Mean (Standard Deviation)
Unit of Measure: units on scale
-1.1  (2.31)
4.Primary Outcome
Title Number of Subjects With Treatment Emergent Adverse Events
Hide Description Adverse events that occur or worsen after the first dose of Avinza
Time Frame Up to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1487
Measure Type: Number
Unit of Measure: participants
707
5.Primary Outcome
Title Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with risk level assessment at Visit 3 (Week 6)
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 769
Measure Type: Number
Unit of Measure: participants
Low risk 433
Moderate risk 325
High risk 8
Missing 3
6.Primary Outcome
Title Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with risk level assessment at Visit 4 (Week 10)
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 633
Measure Type: Number
Unit of Measure: participants
Low risk 355
Moderate risk 267
High risk 7
Missing 4
7.Secondary Outcome
Title Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with risk level assessment at Visit 4 (Week 10)
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1487
Measure Type: Number
Unit of Measure: cases
Satisfied / Very Satisfied 1010
Neutral 278
Dissatisfied / Very dissatisfied 56
Missing 143
8.Secondary Outcome
Title Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 219
Measure Type: Number
Unit of Measure: investigators
Use of at least one tool 206
Use of no tools 13
9.Secondary Outcome
Title Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.
Arm/Group Title Avinza
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 169
Measure Type: Number
Unit of Measure: investigators
Use of at least one tool 156
Use of no tools 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Avinza
Hide Arm/Group Description 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.
All-Cause Mortality
Avinza
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Avinza
Affected / at Risk (%) # Events
Total   60/1487 (4.03%)    
Blood and lymphatic system disorders   
Anaemia  1  2/1487 (0.13%)  2
Neutropenia  1  1/1487 (0.07%)  2
Cardiac disorders   
Cardiac failure congestive  1  4/1487 (0.27%)  4
Myocardial infarction  1  2/1487 (0.13%)  2
Acute myocardial infarction  1  1/1487 (0.07%)  1
Cor pulmonale  1  1/1487 (0.07%)  1
Congenital, familial and genetic disorders   
Hydrocele  1  1/1487 (0.07%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  4/1487 (0.27%)  4
Nausea  1  4/1487 (0.27%)  4
Constipation  1  3/1487 (0.20%)  3
Vomiting  1  3/1487 (0.20%)  3
Abdominal pain  1  1/1487 (0.07%)  1
Colitis  1  1/1487 (0.07%)  1
Colitis ischaemic  1  1/1487 (0.07%)  1
Diarrhoea  1  1/1487 (0.07%)  1
Gastric ulcer perforation  1  1/1487 (0.07%)  1
Gastritis  1  1/1487 (0.07%)  1
Intestinal obstruction  1  1/1487 (0.07%)  1
General disorders   
Accidential death  1  1/1487 (0.07%)  1
Chest pain  1  1/1487 (0.07%)  1
Drug withdrawal syndrome  1  1/1487 (0.07%)  1
Oedema peripheral  1  1/1487 (0.07%)  1
Hepatobiliary disorders   
Cholelithiasis  1  1/1487 (0.07%)  1
Infections and infestations   
Pneumonia  1  8/1487 (0.54%)  8
Cellulitis  1  2/1487 (0.13%)  2
Septic shock  1  2/1487 (0.13%)  2
Diverticulitis  1  1/1487 (0.07%)  1
Gastroenteritis viral  1  1/1487 (0.07%)  1
Lobar pneumonia  1  1/1487 (0.07%)  1
Oesophageal candidiasis  1  1/1487 (0.07%)  1
Urinary tract infection  1  1/1487 (0.07%)  1
Injury, poisoning and procedural complications   
Ankle fracture  1  1/1487 (0.07%)  1
Fall  1  1/1487 (0.07%)  1
Investigations   
Heart rate decreased  1  1/1487 (0.07%)  1
Respiratory rate decreased  1  1/1487 (0.07%)  1
Metabolism and nutrition disorders   
Hypoglycaemia  1  4/1487 (0.27%)  4
Dehydration  1  2/1487 (0.13%)  2
Hypokalaemia  1  2/1487 (0.13%)  2
Diabetic ketoacidosis  1  1/1487 (0.07%)  1
Hyperkalaemia  1  1/1487 (0.07%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  2/1487 (0.13%)  2
Rhabdomyolysis  1  2/1487 (0.13%)  2
Arthralgia  1  1/1487 (0.07%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm malignant  1  1/1487 (0.07%)  1
Pancreatic carcinoma  1  1/1487 (0.07%)  1
Nervous system disorders   
Cerebrovascular accident  1  3/1487 (0.20%)  3
Syncope  1  2/1487 (0.13%)  2
Complicated migraine  1  1/1487 (0.07%)  1
Dizziness  1  1/1487 (0.07%)  1
Grand mal convulsion  1  1/1487 (0.07%)  1
Hemiparesis  1  1/1487 (0.07%)  1
Hepatic encephalopathy  1  1/1487 (0.07%)  1
Lethargy  1  1/1487 (0.07%)  1
Serotonin syndrome  1  1/1487 (0.07%)  1
Psychiatric disorders   
Agitation  1  1/1487 (0.07%)  1
Hallucination  1  1/1487 (0.07%)  1
Mental status changes  1  1/1487 (0.07%)  1
Restlessness  1  1/1487 (0.07%)  1
Renal and urinary disorders   
Renal failure acute  1  5/1487 (0.34%)  5
Renal failure  1  1/1487 (0.07%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  3/1487 (0.20%)  3
Respiratory failure  1  2/1487 (0.13%)  2
Acute interstitial pneumonitis  1  1/1487 (0.07%)  1
Chronic obstructive pulmonary disease  1  1/1487 (0.07%)  1
Pulmonary embolism  1  1/1487 (0.07%)  1
Surgical and medical procedures   
Knee arthroplasty  1  1/1487 (0.07%)  1
Vascular disorders   
Deep vein thrombosis  1  1/1487 (0.07%)  1
Haemorrhage  1  1/1487 (0.07%)  1
Peripheral vascular disorder  1  1/1487 (0.07%)  1
Shock  1  1/1487 (0.07%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Avinza
Affected / at Risk (%) # Events
Total   394/1487 (26.50%)    
Gastrointestinal disorders   
Constipation  1  203/1487 (13.65%)  218
Nausea  1  162/1487 (10.89%)  170
Vomiting  1  78/1487 (5.25%)  80
Nervous system disorders   
Somnolence  1  79/1487 (5.31%)  88
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results may only be published through Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professional Information Services
Organization: King Pharmaceuticals, Inc.
Phone: 1-800-776-3637
Publications:
The American Pain Foundation. Pain Facts & Figures. January 2007. Available from http://www.painfoundation.org/print.asp?file=Newsroom/PainFacts.htm.
Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00640042    
Other Study ID Numbers: K284-07-4001
First Submitted: March 13, 2008
First Posted: March 20, 2008
Results First Submitted: November 30, 2009
Results First Posted: February 15, 2010
Last Update Posted: June 11, 2012