PMID- 25531960
OWN - NLM
STAT- MEDLINE
DCOM- 20150415
LR  - 20220331
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 10
IP  - 6
DP  - 2014 Nov-Dec
TI  - 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.
PG  - 423-36
LID - jom.2014.0239 [pii]
LID - 10.5055/jom.2014.0239 [doi]
AB  - OBJECTIVE: To evaluate the long-term safety of oxycodone-hydrochloride and 
      sequestered naltrexone-hydrochloride (ALO-02) administered for up to 12 months. 
      DESIGN: Open-label, single-arm safety study. SETTING: Thirty-two US research 
      centers (ClinicalTrials.gov identifier NCT01428583). PATIENTS: Three hundred 
      ninety-five adults (opioid experienced and opioid naive) with moderate-to-severe 
      chronic noncancer pain (CNCP). INTERVENTIONS: Open-label, oral ALO-02 capsules, 
      daily dose ranging from 20 to 160 mg oxycodone for up to 12 months. MAIN OUTCOME 
      MEASURES: Number and type of adverse events (AEs) and drugrelated AEs, including 
      assessments of withdrawal (Clinical Opiate Withdrawal Scale; COWS), 
      pharmacokinetics, efficacy, and aberrant behaviors (Current Opioid Misuse 
      Measure). RESULTS: A total of 193 (48.9 percent) patients received ALO-02 for 
      >/=181 days and 105 (26.6 percent) patients for >/=361 days. The most common 
      treatment-emergent AEs were nausea (25.3 percent), constipation (21.3 percent), 
      vomiting (13.9 percent), and headache (11.6 percent). The most common 
      drug-related AEs were constipation (18.0 percent), nausea (14.9 percent), 
      somnolence (8.4 percent), fatigue (6.8 percent), dizziness (5.6 percent), and 
      vomiting (5.1 percent). A majority of patients (86.6 percent) had a maximum COWS 
      total score below the level for mild withdrawal symptoms at every visit 
      throughout the study. Pain severity scores as measured by the short Form of the 
      Brief Pain Inventory (BPI-SF) decreased over time. CONCLUSIONS: Repeat dosing of 
      ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of 
      both opioid-experienced and opioid-naive patients. ALO-02 demonstrated a safety 
      profile consistent with extended-release opioids and the expected analgesic 
      efficacy. The addition of sequestered naltrexone had no significant clinical 
      effect on patients when taken as directed.
FAU - Arora, Samir
AU  - Arora S
AD  - Columbus Clinical Research, Columbus, Ohio.
FAU - Setnik, Beatrice
AU  - Setnik B
AD  - Pfizer Inc., Durham, North Carolina.
FAU - Michael, Drass
AU  - Michael D
AD  - Allegheny Pain Management, Altoona, Pennsylvania.
FAU - Hudson, John D
AU  - Hudson JD
AD  - Future Search Trials of Neurology, Austin, Texas.
FAU - Clemmer, Ray
AU  - Clemmer R
AD  - Pfizer Inc., Groton, Connecticut.
FAU - Meisner, Paul
AU  - Meisner P
AD  - Pfizer Inc., Durham, North Carolina.
FAU - Pixton, Glenn C
AU  - Pixton GC
AD  - Pfizer Inc., Durham, North Carolina.
FAU - Goli, Veeraindar
AU  - Goli V
AD  - Pfizer Inc., Durham, North Carolina; Duke University Medical Center, Durham, 
      North Carolina.
FAU - Sommerville, Kenneth W
AU  - Sommerville KW
AD  - Pfizer Inc., Durham, North Carolina; Duke University Medical Center, Durham, 
      North Carolina.
LA  - eng
SI  - ClinicalTrials.gov/NCT01428583
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Capsules)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Drug Combinations)
RN  - 0 (Narcotic Antagonists)
RN  - 0 (oxycodone naloxone combination)
RN  - 36B82AMQ7N (Naloxone)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*administration & dosage/adverse 
      effects/chemistry/pharmacokinetics
MH  - Capsules
MH  - Chemistry, Pharmaceutical
MH  - Chronic Pain/diagnosis/*drug therapy
MH  - Delayed-Action Preparations
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Drug Dosage Calculations
MH  - Drug Monitoring
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Naloxone/*administration & dosage/adverse effects/chemistry/pharmacokinetics
MH  - Narcotic Antagonists/*administration & dosage/adverse 
      effects/chemistry/pharmacokinetics
MH  - Oxycodone/*administration & dosage/adverse effects/chemistry/pharmacokinetics
MH  - Pain Measurement
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
EDAT- 2014/12/23 06:00
MHDA- 2015/04/16 06:00
CRDT- 2014/12/23 06:00
PHST- 2014/03/30 00:00 [received]
PHST- 2014/06/20 00:00 [revised]
PHST- 2014/07/24 00:00 [accepted]
PHST- 2014/12/23 06:00 [entrez]
PHST- 2014/12/23 06:00 [pubmed]
PHST- 2015/04/16 06:00 [medline]
AID - jom.2014.0239 [pii]
AID - 10.5055/jom.2014.0239 [doi]
PST - ppublish
SO  - J Opioid Manag. 2014 Nov-Dec;10(6):423-36. doi: 10.5055/jom.2014.0239.