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

NCT01571362

Last updated date
Study Location
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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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.

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Chronic Pain, Low Back Pain, AnalgesiaA Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain NCT01571362
  1. Mobile, Alabama
  2. Goodyear, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Anaheim, California
  6. Carmichael, California
  7. Fair Oaks, California
  8. Fresno, California
  9. Laguna Hills, California
  10. Long Beach, California
  11. Long Beach, California
  12. North Hollywood, California
  13. Colorado Springs, Colorado
  14. Colorado Springs, Colorado
  15. DeLand, Florida
  16. Ormond Beach, Florida
  17. Plantation, Florida
  18. Plantation, Florida
  19. Port Orange, Florida
  20. Port Orange, Florida
  21. Tampa, Florida
  22. West Palm Beach, Florida
  23. Marietta, Georgia
  24. Marietta, Georgia
  25. Evansville, Indiana
  26. Hollywood, Maryland
  27. Worcester, Massachusetts
  28. St. Louis, Missouri
  29. Omaha, Nebraska
  30. Las Vegas, Nevada
  31. Albuquerque, New Mexico
  32. Hartsdale, New York
  33. New Windsor, New York
  34. New York, New York
  35. Williamsville, New York
  36. Winston-Salem, North Carolina
  37. Cincinnati, Ohio
  38. Columbus, Ohio
  39. Oklahoma City, Oklahoma
  40. Oklahoma City, Oklahoma
  41. Oklahoma City, Oklahoma
  42. Altoona, Pennsylvania
  43. Duncansville, Pennsylvania
  44. Warwick, Rhode Island
  45. Charleston, South Carolina
  46. Columbia, South Carolina
  47. Austin, Texas
  48. Dallas, Texas
  49. Dallas, Texas
  50. San Antonio, Texas
  51. San Antonio, Texas
  52. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary 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.
Detailed Description Not 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 Date June 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 Committee No
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 Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP