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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00640042
First received: March 13, 2008
Last updated: June 6, 2012
Last verified: June 2012
Results First Received: November 30, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: morphine sulfate extended release capsules

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Enrollment
    Avinza  
STARTED     1570 [1]
COMPLETED     1487 [2]
NOT COMPLETED     83  
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 2:   Treatment
    Avinza  
STARTED     1487  
COMPLETED     561  
NOT COMPLETED     926  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Avinza  
Number of Participants  
[units: participants]
  1487  
Age  
[units: years]
Mean ± Standard Deviation
  52.7  ± 13.62  
Gender, Customized  
[units: participants]
 
Female     839  
Male     630  
Missing     18  
Risk level for opioid misuse or abuse [1]
[units: participants]
 
Low     694  
Moderate     767  
High     19  
Missing     7  
[1] Investigator determined classification of potential risk based on assessment of urine drug tests and patient history and questionnaires



  Outcome Measures
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1.  Primary:   Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)   [ Time Frame: Baseline (Week 0) to Visit 3 (Week 6) ]

2.  Primary:   Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)   [ Time Frame: Baseline (Week 0) to Visit 4 (Week 10) ]

3.  Primary:   Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)   [ Time Frame: Baseline (Week 0) to Visit 5 (Week 14 / End of Study) ]

4.  Primary:   Number of Subjects With Treatment Emergent Adverse Events   [ Time Frame: Up to 4 months ]

5.  Primary:   Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)   [ Time Frame: Visit 3 (Week 6) ]

6.  Primary:   Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)   [ Time Frame: Visit 4 (Week 10) ]

7.  Secondary:   Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.   [ Time Frame: Up to 4 months ]

8.  Secondary:   Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.   [ Time Frame: 3 months post study ]

9.  Secondary:   Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.   [ Time Frame: 6 months post study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Professional Information Services
Organization: King Pharmaceuticals, Inc.
phone: 1-800-776-3637


Publications:
Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00640042     History of Changes
Other Study ID Numbers: K284-07-4001
Study First Received: March 13, 2008
Results First Received: November 30, 2009
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board