Trial Outcomes & Findings for Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza (NCT NCT00640042)
NCT ID: NCT00640042
Last Updated: 2012-06-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1570 participants
Primary outcome timeframe
Baseline (Week 0) to Visit 3 (Week 6)
Results posted on
2012-06-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Enrollment
STARTED
|
1570
|
|
Enrollment
COMPLETED
|
1487
|
|
Enrollment
NOT COMPLETED
|
83
|
|
Treatment
STARTED
|
1487
|
|
Treatment
COMPLETED
|
561
|
|
Treatment
NOT COMPLETED
|
926
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Enrollment
Did not receive study drug
|
83
|
Baseline Characteristics
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
Baseline characteristics by cohort
| Measure |
Avinza
n=1487 Participants
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.
|
|---|---|
|
Age Continuous
|
52.7 years
STANDARD_DEVIATION 13.62 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
839 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
630 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
18 participants
n=5 Participants
|
|
Risk level for opioid misuse or abuse
Low
|
694 participants
n=5 Participants
|
|
Risk level for opioid misuse or abuse
Moderate
|
767 participants
n=5 Participants
|
|
Risk level for opioid misuse or abuse
High
|
19 participants
n=5 Participants
|
|
Risk level for opioid misuse or abuse
Missing
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
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
Outcome measures
| Measure |
Avinza
n=755 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Baseline (Week 0) to Visit 4 (Week 10)Population: Number of subjects with pain scores at Baseline (Week 0) and 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
Outcome measures
| Measure |
Avinza
n=622 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: 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)
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
Outcome measures
| Measure |
Avinza
n=1105 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Up to 4 monthsAdverse events that occur or worsen after the first dose of Avinza
Outcome measures
| Measure |
Avinza
n=1487 Participants
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.
|
|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events
|
707 participants
|
PRIMARY outcome
Timeframe: Visit 3 (Week 6)Population: Number of subjects with risk level assessment 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.
Outcome measures
| Measure |
Avinza
n=769 Participants
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.
|
|---|---|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
Low risk
|
433 participants
|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
Moderate risk
|
325 participants
|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
High risk
|
8 participants
|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)
Missing
|
3 participants
|
PRIMARY outcome
Timeframe: Visit 4 (Week 10)Population: Number of subjects with risk level assessment 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.
Outcome measures
| Measure |
Avinza
n=633 Participants
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.
|
|---|---|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
Low risk
|
355 participants
|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
Moderate risk
|
267 participants
|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
High risk
|
7 participants
|
|
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)
Missing
|
4 participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: Number of subjects with risk level assessment at Visit 4 (Week 10)
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.
Outcome measures
| Measure |
Avinza
n=1487 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 3 months post studyPopulation: Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.
The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
Outcome measures
| Measure |
Avinza
n=219 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 6 months post studyPopulation: Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.
The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
Outcome measures
| Measure |
Avinza
n=169 Participants
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.
|
|---|---|
|
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
|
|
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
|
Adverse Events
Avinza
Serious events: 60 serious events
Other events: 394 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avinza
n=1487 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.13%
2/1487 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.07%
1/1487 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
4/1487 • Number of events 4
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
2/1487 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
1/1487 • Number of events 1
|
|
Cardiac disorders
Cor pulmonale
|
0.07%
1/1487 • Number of events 1
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.07%
1/1487 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.27%
4/1487 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
0.27%
4/1487 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
0.20%
3/1487 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
3/1487 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.07%
1/1487 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.07%
1/1487 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.07%
1/1487 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.07%
1/1487 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.07%
1/1487 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
1/1487 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
1/1487 • Number of events 1
|
|
General disorders
Accidential death
|
0.07%
1/1487 • Number of events 1
|
|
General disorders
Chest pain
|
0.07%
1/1487 • Number of events 1
|
|
General disorders
Drug withdrawal syndrome
|
0.07%
1/1487 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.07%
1/1487 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1487 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.54%
8/1487 • Number of events 8
|
|
Infections and infestations
Cellulitis
|
0.13%
2/1487 • Number of events 2
|
|
Infections and infestations
Septic shock
|
0.13%
2/1487 • Number of events 2
|
|
Infections and infestations
Diverticulitis
|
0.07%
1/1487 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.07%
1/1487 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.07%
1/1487 • Number of events 1
|
|
Infections and infestations
Oesophageal candidiasis
|
0.07%
1/1487 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.07%
1/1487 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1487 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
1/1487 • Number of events 1
|
|
Investigations
Heart rate decreased
|
0.07%
1/1487 • Number of events 1
|
|
Investigations
Respiratory rate decreased
|
0.07%
1/1487 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
4/1487 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
2/1487 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.13%
2/1487 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1487 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.07%
1/1487 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
2/1487 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.13%
2/1487 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
1/1487 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
1/1487 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.07%
1/1487 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
3/1487 • Number of events 3
|
|
Nervous system disorders
Syncope
|
0.13%
2/1487 • Number of events 2
|
|
Nervous system disorders
Complicated migraine
|
0.07%
1/1487 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1487 • Number of events 1
|
|
Nervous system disorders
Grand mal convulsion
|
0.07%
1/1487 • Number of events 1
|
|
Nervous system disorders
Hemiparesis
|
0.07%
1/1487 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.07%
1/1487 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.07%
1/1487 • Number of events 1
|
|
Nervous system disorders
Serotonin syndrome
|
0.07%
1/1487 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.07%
1/1487 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.07%
1/1487 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.07%
1/1487 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
0.07%
1/1487 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.34%
5/1487 • Number of events 5
|
|
Renal and urinary disorders
Renal failure
|
0.07%
1/1487 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
3/1487 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.13%
2/1487 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.07%
1/1487 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.07%
1/1487 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
1/1487 • Number of events 1
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.07%
1/1487 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1487 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
0.07%
1/1487 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
1/1487 • Number of events 1
|
|
Vascular disorders
Shock
|
0.07%
1/1487 • Number of events 1
|
Other adverse events
| Measure |
Avinza
n=1487 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
13.7%
203/1487 • Number of events 218
|
|
Gastrointestinal disorders
Nausea
|
10.9%
162/1487 • Number of events 170
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
78/1487 • Number of events 80
|
|
Nervous system disorders
Somnolence
|
5.3%
79/1487 • Number of events 88
|
Additional Information
Professional Information Services
King Pharmaceuticals, Inc.
Phone: 1-800-776-3637
Results disclosure agreements
- Principal investigator is a sponsor employee Results may only be published through Sponsor.
- Publication restrictions are in place
Restriction type: OTHER