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Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Avail Clinical Research, LLC
Deland, Florida, 32720 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Noncancer Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01428583
Pfizer
Completed
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

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Descriptive Information
Brief Title  ICMJE Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Noncancer Pain
Intervention  ICMJE Drug: oxycodone HCl and naltrexone HCl extended-release capsules
Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)
Other Name: ALO-02
Study Arms  ICMJE Experimental: oxycodone HCl and naltrexone HCl extended-release capsules
Intervention: Drug: oxycodone HCl and naltrexone HCl extended-release capsules
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2011)
395
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion DateMay 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01428583
Other Study ID Numbers  ICMJE ALO-02-10-3001
B4531001 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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