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

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NCT00415597

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Michael Gibson, MD
Birmingham, Alabama, 35244 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.
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.

NCT00415597
Pfizer
Completed
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

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Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
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
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
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
Experimental: ALO-01
Doses given once or twice daily
Intervention: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
467
March 2008
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00415597
ALO-KNT-302
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: James B. Jones, MD, PharmD Alpharma Pharmaceuticals
Pfizer
September 2013

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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