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A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

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NCT01571362

Last updated on December 5, 2019
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FOR MORE INFORMATION
Study Location
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pain, Low Back Pain, Analgesia
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

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

- 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.

NCT01571362
Pfizer
Completed
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

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Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Low Back Pain
  • Analgesia
Intervention  ICMJE
  • Drug: ALO-02
    20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
    Other Name: oxycodone HCl and naltrexone HCl
  • Drug: Placebo
    oral placebo, divided into symmetric doses and administered twice daily
Study Arms  ICMJE
  • Experimental: ALO-02
    Intervention: Drug: ALO-02
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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: February 17, 2017)		410
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2012)		250
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion DateJune 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT01571362
Other Study ID Numbers  ICMJE B4531002
B4531002
ALO-02-10-3002 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
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 DateFebruary 2017

ICMJE     Data element required by the

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

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