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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 October 4, 2018
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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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A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Chronic Pain
  • Low Back Pain
  • Analgesia
  • 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
  • Experimental: ALO-02
    Intervention: Drug: ALO-02
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01571362
B4531002
B4531002
ALO-02-10-3002 ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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