Clinical trial NCT01428583: Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Official title: A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Noncancer Pain
Keywords: Chronic noncancer pain
oxycodone
naltrexone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-05
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.


Eligibility criteria: Inclusion Criteria:

* Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
* Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)

Exclusion Criteria:

* Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
* Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
* Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
* Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
* Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
* If female, the subject is pregnant or breast-feeding.
* Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
* Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions
timeFrame: Baseline up to end of study (2 weeks post-end of month 12)
Secondary outcomes:
measure: Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity
timeFrame: Baseline up to end of study (2 weeks post-end of month 12)
measure: Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score
timeFrame: Baseline up to Month 12
measure: Subjective Opiate Withdrawal Scale (SOWS) Score
timeFrame: Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Other outcomes:
measure: Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone
timeFrame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
measure: Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone
timeFrame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
measure: Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone
timeFrame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
measure: Observed Steady-state Plasma Concentrations (Cobs) of 6-Beta-naltrexol
timeFrame: Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
measure: Time to Stabilization of Study Medication
timeFrame: Baseline up to Month 12
measure: Duration of Exposure to Study Medication
timeFrame: Baseline up to 2 weeks after last dose
measure: Mean Daily Dose of Study Medication (Oxycodone Component)
timeFrame: Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)
measure: Number of Participants With Rescue Medication (Acetaminophen Tablets)
timeFrame: Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)
measure: Percentage of Participants With Response to Urine Drug Test
timeFrame: Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination
measure: Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above
timeFrame: Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination
measure: Mean Daily Dose of Immediate-release Oxycodone as Rescue Medication
timeFrame: Up to Week 4
measure: Participants Global Assessment of Treatment Satisfaction
timeFrame: Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment
measure: Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
timeFrame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)
measure: Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
timeFrame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
measure: Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
timeFrame: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
Locations:
city: Deland
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research, Inc.
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Sarasota Pain Medicine Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Atlanta
country: United States
facility: Center for Prospective Outcome Studies, Inc.
state: Georgia
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: Lexington
country: United States
facility: The Pain Treatment Center of the Bluegrass
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research
state: Kentucky
city: Owings Mills
country: United States
facility: Crossroads Research
state: Maryland
city: Springfield
country: United States
facility: DM Clinical Research
state: Massachusetts
city: Edina
country: United States
facility: MAPS Applied Research Center
state: Minnesota
city: Southaven
country: United States
facility: Mid-South Anesthesia Consultants
state: Mississippi
city: Hazelwood
country: United States
facility: Healthcare Research, LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience Institute
state: Montana
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Hartsdale
country: United States
facility: Drug Trials America - New York
state: New York
city: North Syracuse
country: United States
facility: New York Spine and Wellness Center
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Winston-Salem
country: United States
facility: Center for Clinical Research, LLC - Winston-Salem
state: North Carolina
city: Columbus
country: United States
facility: Columbus Clinical Research, Inc.
state: Ohio
city: Altoona
country: United States
facility: Allegheny Pain Management, PC
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research - Fort Worth
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Roanoke
country: United States
facility: Hypothetest, LLC
state: Virginia
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: Arora S, Setnik B, Michael D, Hudson JD, Clemmer R, Meisner P, Pixton GC, Goli V, Sommerville KW. A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain. J Opioid Manag. 2014 Nov-Dec;10(6):423-36. doi: 10.5055/jom.2014.0239.