Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00415597
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : October 29, 2009
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 21, 2006
First Posted Date  ICMJE December 25, 2006
Results First Submitted Date  ICMJE September 11, 2009
Results First Posted Date  ICMJE October 29, 2009
Last Update Posted Date September 20, 2013
Study Start Date  ICMJE December 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Subjects With Treatment Emergent Adverse Events [ Time Frame: up to 12 months ]
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
To evaluate the long-term safety of Kadian NT administered for up to 12 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
  • Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 12 weeks ]
    Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
  • Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 52 weeks ]
    Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
  • Evaluate the long-term efficacy of Kadian NT during a 12-month period by assessing pain intensity (PI)
  • in the past 24 hours using the Brief Pain Inventory (BPI) Short Form, and the Global Assessment of Study Drug
  • Evaluate opioid withdrawal symptoms in subjects who receive Kadian NT upon completion of 12-months exposure
  • or early termination from the study using the Clinical Opiate Withdrawal Scale (COWS)
  • Evaluate plasma naltrexone, 6-B-naltrexol, and morphine concentrations at Visits 2 through 15 in selected male
  • and female subjects for pharmacokinetic study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, PharmD Alpharma 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