A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

NCT00420992

Last updated date
Study Location
The Birmingham Pain Center
Birmingham, Alabama, 35244, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject is 21 years of age or older

- Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential

- Negative pregnancy test if female of childbearing potential

- Subject is in general good health

- Subject required treatment of joint pain within the last 90 days

- Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

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


- Subject has a documented history of allergic reaction or intolerance to morphine or
other opioids


- Subject is pregnant or breast-feeding


- Subject is receiving systemic chemotherapy


- Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence


- Subject has history of major depressive disorder not controlled with medication


- Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the
symptoms of OA


- Subject has active gastrointestinal disease, with the exception of gastroesophageal
reflux disease (GERD)


- Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory
arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory
arthritis

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Osteoarthritis, Chronic PainA Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
NCT00420992
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Peoria, Arizona
  4. Phoenix, Arizona
  5. Tempe, Arizona
  6. Anaheim, California
  7. Anaheim, California
  8. Anaheim, California
  9. Buena Park, California
  10. Burbank, California
  11. Fair Oaks, California
  12. Hawaiian Gardens, California
  13. Irvine, California
  14. La Jolla, California
  15. La Jolla, California
  16. Pico Rivera, California
  17. Santa Monica, California
  18. Upland, California
  19. Denver, Colorado
  20. Stamford, Connecticut
  21. Trumbull, Connecticut
  22. Hallandale Beach, Florida
  23. Hialeah, Florida
  24. Jacksonville, Florida
  25. Jupiter, Florida
  26. Kissimmee, Florida
  27. Largo, Florida
  28. Merritt Island, Florida
  29. Ormond Beach, Florida
  30. Pembroke Pines, Florida
  31. Port Orange, Florida
  32. Tampa, Florida
  33. Weston, Florida
  34. Blue Ridge, Georgia
  35. Decatur, Georgia
  36. Marietta, Georgia
  37. Marietta, Georgia
  38. Boise, Idaho
  39. Peoria, Illinois
  40. Evansville, Indiana
  41. Newburgh, Indiana
  42. Overland Park, Kansas
  43. Mandeville, Louisiana
  44. New Orleans, Louisiana
  45. Towson, Maryland
  46. Fall River, Massachusetts
  47. No Dartmouth, Massachusetts
  48. Springfield, Massachusetts
  49. Saginaw, Michigan
  50. St. Louis, Missouri
  51. Henderson, Nevada
  52. Las Vegas, Nevada
  53. Voorhees, New Jersey
  54. Mount Vernon, New York
  55. Charlotte, North Carolina
  56. Winston-Salem, North Carolina
  57. Cincinnati, Ohio
  58. Cincinnati, Ohio
  59. Toledo, Ohio
  60. Oklahoma City, Oklahoma
  61. Oklahoma City, Oklahoma
  62. Oklahoma City, Oklahoma
  63. Tulsa, Oklahoma
  64. Allentown, Pennsylvania
  65. Bensalem, Pennsylvania
  66. Duncansville, Pennsylvania
  67. Fleetwood, Pennsylvania
  68. Souderton, Pennsylvania
  69. Tipton, Pennsylvania
  70. Clarksville, Tennessee
  71. Cordova, Tennessee
  72. Hendersonville, Tennessee
  73. Memphis, Tennessee
  74. Milan, Tennessee
  75. Austin, Texas
  76. DeSoto, Texas
  77. Killeen, Texas
  78. San Antonio, Texas
  79. San Antonio, Texas
  80. San Antonio, Texas
  81. Roanoke, Virginia
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee
Brief Summary The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
Detailed Description The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.
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
  • Osteoarthritis
  • Chronic Pain
Intervention  ICMJE
  • Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
    capsules, up to 80 mg bid
    Other Name: Embeda
  • Drug: Placebo
    capsules, bid
Study Arms  ICMJE
  • Experimental: ALO-01
    Up to 80 mg twice a day (bid)
    Intervention: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
  • Placebo Comparator: Placebo
    Twice a day (bid)
    Intervention: Drug: Placebo
Publications * Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.

*   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: October 28, 2009)
547
Original Enrollment  ICMJE
 (submitted: January 10, 2007)
400
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is 21 years of age or older
  • Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
  • Negative pregnancy test if female of childbearing potential
  • Subject is in general good health
  • Subject required treatment of joint pain within the last 90 days
  • Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

Exclusion Criteria:

  • Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
  • Subject is pregnant or breast-feeding
  • Subject is receiving systemic chemotherapy
  • Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
  • Subject has history of major depressive disorder not controlled with medication
  • Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
  • Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
  • Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 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 NCT00420992
Other Study ID Numbers  ICMJE ALO-KNT-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:James B. Jones, MD, PharmDAlpharma Pharmceuticals
PRS Account Pfizer
Verification Date September 2013

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