Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

NCT00415597

Last updated date
Study Location
Michael Gibson, MD
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.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject 18-70 years of age

- Subject agrees to refrain from taking any opioid medications other than study medication during study period.

- History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline

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 clinically significant
intolerance to morphine or other opioids, such that treatment with morphine is
contraindicated.


- Subject is pregnant or breast-feeding.


- Subject is receiving chemotherapy, or has an active malignancy of any type or has been
diagnosed with cancer within the past three years (excluding squamous or basal cell
carcinoma of the skin).


- Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic
abuse/dependence/misuse within five years prior to the Baseline Visit.


- Subject has a Body Mass Index (BMI)>45kg/m2.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Official Title  ICMJE A Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Brief Summary Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily
Other Name: Embeda
Study Arms  ICMJE Experimental: ALO-01
Doses given once or twice daily
Intervention: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
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: March 5, 2009)
467
Original Enrollment  ICMJE
 (submitted: December 21, 2006)
400
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject 18-70 years of age
  • Subject agrees to refrain from taking any opioid medications other than study medication during study period.
  • History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline

Exclusion Criteria:

  • Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated.
  • Subject is pregnant or breast-feeding.
  • Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin).
  • Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit.
  • Subject has a Body Mass Index (BMI)>45kg/m2.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (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 NCT00415597
Other Study ID Numbers  ICMJE ALO-KNT-302
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 Pharmaceuticals
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