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

September 13, 2013 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
547

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • The Birmingham Pain Center
      • Mobile, Alabama, United States, 36608
        • Horizon Research Group
    • Arizona
      • Peoria, Arizona, United States, 85383
        • Arizona Center For Clinical Research
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center, Inc
      • Tempe, Arizona, United States, 85282
        • Premiere Pharmaceutical Research, LLC
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trials
      • Anaheim, California, United States, 92804
        • STAT-CARE / Crest Clinical Trials
      • Buena Park, California, United States, 90620
        • Southbay Pharma Research
      • Burbank, California, United States, 91505
        • Providence Clinical Res. (C-trials)
      • Fair Oaks, California, United States, 95628
        • Med Investigators Inc
      • Hawaiian Gardens, California, United States, 90716
        • Quality of Life Medical Center, LLC
      • Irvine, California, United States, 92618
        • NervePro Research
      • La Jolla, California, United States, 92093
        • UCSD Pain and Palliative Care
      • La Jolla, California, United States, 92093
        • USCD Pain and Palliative Care
      • Pico Rivera, California, United States, 90660
        • Private Practice
      • Santa Monica, California, United States, 90404
        • Pain Institute of Santa Monica
      • Upland, California, United States, 91786
        • Boling Clinical Trials
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research, Inc
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
      • Trumbull, Connecticut, United States, 06611
        • New England Research Associates, LLC
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Hialeah, Florida, United States, 33013
        • Eastern Research
      • Jacksonville, Florida, United States, 32257
        • Florida Institute of Medical Research
      • Jupiter, Florida, United States, 33458
        • Drug Study Institiute
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • Largo, Florida, United States, 33770
        • Innovative Research of West Florida
      • Merritt Island, Florida, United States, 32953
        • Pharmaceutical Research Associates Inc
      • Ormond Beach, Florida, United States, 32174
        • Ormond Medical Arts - Pharmaceutical Research Center
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • Weston, Florida, United States, 33331
        • Gold Coast Research LLC
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • River Birch Research Alliance
      • Decatur, Georgia, United States, 30034
        • Best Clinical Research
      • Marietta, Georgia, United States, 30066
        • Drug Studies America
      • Marietta, Georgia, United States, 30060
        • Non-Surgical Orthopaedic and Spine Center
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Research Associates of Central Illinois
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Newburgh, Indiana, United States, 47630
        • Welborn Clinic
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • International Clinical Research Institute, Inc
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Clinical Trials Management, LLC
      • New Orleans, Louisiana, United States, 70114
        • Lousiana Research Associates Inc.
    • Maryland
      • Towson, Maryland, United States, 21286
        • Internal Research Center
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Phase III Clinical Research
      • No Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc
      • Springfield, Massachusetts, United States, 01107
        • FutureCare Studies
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Synergy Medical Education Alliance
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Medex Healthcare Research Inc
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Lovelace Scientific
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Partners in Primary Care
    • New York
      • Mount Vernon, New York, United States, 10550
        • Elkind Headache Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • The Arthritis Clinic and Carolina Bone and Joint
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Community Research
      • Cincinnati, Ohio, United States, 45245
        • Community Research
      • Toledo, Ohio, United States, 43551
        • Clinical Research Source, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Health Research Institute
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research
      • Tulsa, Oklahoma, United States, 74101
        • Tulsa Clinical Research
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • LVH Neurosciences and Pain Research
      • Bensalem, Pennsylvania, United States, 19020
        • Pennsylvania Research Institute
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Fleetwood, Pennsylvania, United States, 19522
        • Commonwealth Primary Care / Fleetwood Clinical Research
      • Souderton, Pennsylvania, United States, 18964
        • Pivotal Clinical Research, Llc
      • Tipton, Pennsylvania, United States, 16684
        • Tipton Medical and Diagnostic Center
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Premier Medical Group
      • Cordova, Tennessee, United States, 38018
        • SCRI
      • Hendersonville, Tennessee, United States, 37075
        • Comprehensive Pain Specialists
      • Memphis, Tennessee, United States, 38119
        • SCRI
      • Milan, Tennessee, United States, 38358
        • Integrity Clinical Research, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Walter F. Chase, MD, PA
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Killeen, Texas, United States, 76543
        • Team Research of Central Texas
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, United States, 78218
        • North San Antonio Healthcare Associates
      • San Antonio, Texas, United States, 78217
        • Radiant Research, San Antonio Northeast
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • HypotheTest, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALO-01
Up to 80 mg twice a day (bid)
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
capsules, up to 80 mg bid
Other Names:
  • Embeda
Placebo Comparator: Placebo
Twice a day (bid)
Drug: Placebo
capsules, bid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
Time Frame: randomization to 12 weeks following randomization
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
randomization to 12 weeks following randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: James B. Jones, MD, PharmD, Alpharma Pharmceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALO-KNT-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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