Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza

Pain Clinical Trial

— ACCESS 2008  

Official title:

AVINZA Control of Chronic Pain, Effectiveness and Safety Study (ACCESS 2008) A Multi-Center Study to Evaluate the Effectiveness and Tolerability of AVINZA for Chronic Moderate-Severe Pain: A Focus on Risk Minimization Assessment, Intervention and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640042
• Other study ID #: K284-07-4001
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2008
• Last updated: June 6, 2012
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1570
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Drug:
• morphine 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (9)

Caldwell JR, Rapoport RJ, Davis JC, Offenberg HL, Marker HW, Roth SH, Yuan W, Eliot L, Babul N, Lynch PM. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002 Apr;23(4):278-91. — View Citation

Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005 Mar-Apr;6(2):107-12. — View Citation

Ives TJ, Chelminski PR, Hammett-Stabler CA, Malone RM, Perhac JS, Potisek NM, Shilliday BB, DeWalt DA, Pignone MP. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006 Apr 4;6:46. — View Citation

Joranson DE, Berger JW. Regulatory issues in pain management. J Am Pharm Assoc (Wash). 2000 Sep-Oct;40(5 Suppl 1):S60-1. — View Citation

Katz NP, Adams EH, Chilcoat H, Colucci RD, Comer SD, Goliber P, Grudzinskas C, Jasinski D, Lande SD, Passik SD, Schnoll SH, Sellers E, Travers D, Weiss R. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007 Oct;23(8):648-60. Review. — View Citation

Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial. J Opioid Manag. 2006 Nov-Dec;2(6):325-8, 331-3. — View Citation

Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain. J Opioid Manag. 2006 May-Jun;2(3):155-66. Erratum in: J Opioid Manag. 2006 Sep-Oct;2(5):276. — View Citation

Rosenthal M, Moore P, Groves E, Iwan T, Schlosser LG, Dziewanowska Z, Negro-Vilar A. Sleep improves when patients with chronic OA pain are managed with morning dosing of once a day extended-release morphine sulfate (AVINZA): findings from a pilot study. J Opioid Manag. 2007 May-Jun;3(3):145-54. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline (Week 0) to Visit 3 (Week 6)	No
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	Baseline (Week 0) to Visit 4 (Week 10)	No
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	Baseline (Week 0) to Visit 5 (Week 14 / End of Study)	No
Primary	Number of Subjects With Treatment Emergent Adverse Events	Adverse events that occur or worsen after the first dose of Avinza	Up to 4 months	Yes
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.	Visit 3 (Week 6)	No
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.	Visit 4 (Week 10)	No
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.	Up to 4 months	No
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.	3 months post study	No
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.	6 months post study	No