Clinical trial NCT01571362: A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
Official title: A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Low Back Pain
Analgesia
Keywords: oxycodone
naltrexone
chronic pain
low back pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* Moderate-to-severe chronic low back pain present for at least 3 months.
* Require a continuous around-the-clock opioid analgesic for an extended period of time.
* Refrain from taking other opioid and non-opioid medications during the study.

Exclusion Criteria:

* Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.
* Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.
* Active or ongoing or history of alcohol or drug abuse.

Primary outcomes:
measure: Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)
timeFrame: Weeks 11 and 12
Secondary outcomes:
measure: Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).
timeFrame: Week 12
measure: Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).
timeFrame: Randomization Baseline, Week 12
measure: Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%
timeFrame: Weeks 11 and 12
measure: Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%
timeFrame: Weeks 11 and 12
measure: Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%
timeFrame: Weeks 11 and 12
measure: Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%
timeFrame: Weeks 11 and 12
measure: Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
timeFrame: Screening, Week 4, 5, or 6
measure: Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
timeFrame: Screening, Randomization Baseline
measure: Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
timeFrame: Weeks 2, 4, 8 and 12
measure: Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
timeFrame: Weeks 2, 4, 8, and 12
measure: Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
timeFrame: Weeks 2, 4, 8, and 12
measure: Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)
timeFrame: Randomization Baseline, Weeks 11 and 12
measure: Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period
timeFrame: Daily from Day 1 of the Double-Blind Period through Week 12
measure: Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
timeFrame: Screening, Week 4, 5 or 6
measure: Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
timeFrame: Screening, Week 4, 5, or 6
measure: Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
timeFrame: Screening, Randomization Baseline (up to 6 weeks)
measure: Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
timeFrame: Screening, Randomization Baseline (up to 6 weeks)
measure: Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period
timeFrame: Randomization Baseline, up to Week 12
measure: Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period
timeFrame: Randomization Baseline, up to Week 12
measure: Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy
timeFrame: Week 1 up to Week 12
measure: Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period
timeFrame: Week 1 up to Week 12
measure: Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period
timeFrame: Screening, Weeks 1, 2, 3, 4, 5, and 6
measure: COWS Total Score During the Double-Blind Treatment Period
timeFrame: Randomization Baseline, Weeks 1, 2, 4, 8, and 12
measure: COWS Total Score During the Post-Treatment Period
timeFrame: Follow-Up (FU) Weeks 1 and 2
measure: Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category
timeFrame: Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)
measure: Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category
timeFrame: Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)
measure: Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category
timeFrame: Follow-Up Weeks 1 and 2
measure: Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period
timeFrame: Screening, Weeks 1, 2, 3, 4, 5, and 6
measure: SOWS Total Score During the Double-Blind Treatment Period
timeFrame: Randomization Baseline, Weeks 1, 2, 4, 8, and 12
measure: SOWS Total Score During the Post-Treatment Period
timeFrame: Follow-Up Weeks 1 and 2
measure: Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants
timeFrame: Screening, Week 6 (or Early Termination)
measure: Change From Screening Period to Randomization Baseline in RMDQ Total Score
timeFrame: Screening, Randomization Baseline
measure: Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score
timeFrame: Screening, Weeks 2, 4, 8, and 12
measure: Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score
timeFrame: Randomization Baseline, Weeks 2, 4, and 8
measure: Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
timeFrame: Screening, Randomization Baseline
measure: Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
timeFrame: Screening, Randomization Baseline, or Early Termination
measure: Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor
timeFrame: Randomization Baseline, Week 4
measure: Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor
timeFrame: Randomization Baseline, Week 8
measure: Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants
timeFrame: End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)
measure: Satisfaction With Treatment at Randomization Baseline
timeFrame: Randomization Baseline
measure: Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period
timeFrame: Week 12 or Early Termination
measure: Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score
timeFrame: Screening, Week 6 (or Early Termination)
measure: Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score
timeFrame: Screening, Randomization Baseline
measure: Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
timeFrame: Randomization Baseline, Week 12
measure: Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
timeFrame: Screening, Week 12
measure: Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index
timeFrame: Screening, Week 6 (or Early Termination)
measure: Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS
timeFrame: Screening, Week 6 (or Early Termination)
measure: Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index
timeFrame: Screening, Randomization Baseline
measure: Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS
timeFrame: Screening, Randomization Baseline
measure: Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
timeFrame: Randomization Baseline, Week 12
measure: Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS
timeFrame: Randomization Baseline, Week 12
measure: Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
timeFrame: Screening, Week 12
measure: Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS
timeFrame: Screening, Week 12
measure: Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain
timeFrame: Screening, Week 6 (or Early Termination)
measure: Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain
timeFrame: Screening, Randomization Baseline
measure: Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
timeFrame: Randomization Baseline, Weeks 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
timeFrame: Randomization Baseline, Weeks 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
timeFrame: Randomization Baseline, Weeks 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
timeFrame: Randomization Baseline, Weeks 4, 8, and 12
measure: Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
timeFrame: Screening, Weeks 4, 8, and 12
measure: Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
timeFrame: Screening, Weeks 4, 8, and 12
measure: Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
timeFrame: Screening, Weeks 4, 8, and 12
measure: Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
timeFrame: Screening, Weeks 4, 8, and 12
measure: Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire
timeFrame: Screening, Week 6 (or Early Termination)
measure: Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
timeFrame: Screening, Randomization Baseline
measure: Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
timeFrame: Screening, Randomization Baseline
measure: Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
timeFrame: Screening, Randomization Baseline
measure: Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital
timeFrame: Screening, Randomization Baseline
measure: Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
timeFrame: Screening, Week 6 (or Early Termination)
measure: Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
timeFrame: Screening, Week 6 (or Early Termination)
measure: Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital
timeFrame: Screening, Week 6 (or Early Termination)
measure: Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
timeFrame: Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)
measure: Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain
timeFrame: Randomization Baseline, Weeks 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments
timeFrame: Randomization Baseline, Weeks 4, 8, and 12
measure: Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital
timeFrame: Randomization Baseline, Weeks 4, 8, and 12
measure: Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
timeFrame: Screening, Weeks 4, 8, and 12
measure: Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain
timeFrame: Screening, Weeks 4, 8, and 12
measure: Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain
timeFrame: Screening, Weeks 4, 8, and 12
measure: Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain
timeFrame: Screening, Weeks 4, 8, and 12
measure: Mean Oxycodone Average Daily Dose During the Open-Label Titration Period
timeFrame: Open-Label Period
measure: Mean Oxycodone Duration of Titration During the Open-Label Titration Period
timeFrame: Open-Label Period
measure: Median Oxycodone Average Daily Dose During the Open-Label Titration Period
timeFrame: Open-Label Period
measure: Median Oxycodone Duration of Titration During the Open-Label Titration Period
timeFrame: Open-Label Period
measure: Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period
timeFrame: Double-Blind Period
measure: Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period
timeFrame: Double-Blind Period
measure: Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period
timeFrame: Double-Blind Period
measure: Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period
timeFrame: Double-Blind Period
measure: Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period
timeFrame: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline
measure: Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period
timeFrame: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline
measure: Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period
timeFrame: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12
measure: Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period
timeFrame: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Premier Research Group Limited
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Carmichael
country: United States
facility: Med Center
state: California
city: Fair Oaks
country: United States
facility: Med Investigations, Inc.
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Laguna Hills
country: United States
facility: Pacific Coast Pain Management Center
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research - previous addresse
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies Medical Centre
state: Colorado
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts pharmaceutical Research Center
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Plantation
country: United States
facility: The Office of Martin E. Hale, MD, PA
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC- Duplicate 2
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC- Duplicate
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research - Research Department
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Office of Stephen H. Miller, M.D.
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: New York
country: United States
facility: Research Across America
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Associated Orthopedics
state: Oklahoma
city: Oklahoma City
country: United States
facility: Hillcrest Clinical Research
state: Oklahoma
city: Altoona
country: United States
facility: Allegheny Pain Management, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Pain Research of Charleston
state: South Carolina
city: Columbia
country: United States
facility: TLM Medical Services
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Lee Medical Associates
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, P.A.
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gimbel JS, Rauck RL, Bass A, Wilson J, Pixton G, Malhotra B, Wilson G, Wolfram G. Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. J Opioid Manag. 2019 Sep/Oct;15(5):417-427. doi: 10.5055/jom.2019.0530.
citation: Wilson JG, Bass A, Pixton GC, Wolfram G, Rauck RL. Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.
citation: Weil AJ, Masters ET, Barsdorf AI, Bass A, Pixton G, Wilson JG, Wolfram G. Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain. Health Qual Life Outcomes. 2017 Oct 17;15(1):202. doi: 10.1186/s12955-017-0749-y.
citation: Rauck RL, Hale ME, Bass A, Bramson C, Pixton G, Wilson JG, Setnik B, Meisner P, Sommerville KW, Malhotra BK, Wolfram G. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Pain. 2015 Sep;156(9):1660-1669. doi: 10.1097/j.pain.0000000000000230.