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PainPhase 3NCT00415597

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

A Phase 3 study testing ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) in people with Pain, run by Pfizer at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pain
What is being tested?
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
467 participants
Where
58 sitesUnited States
Study dates
Dec 2006to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • Barbara McGuire, MD

    Albuquerque, New Mexico, 87108

  • Steve Sitar, MD

    Anaheim, California, 92801

  • Robert Burton, MD

    Anaheim, California, 92804

  • Walter Chase, MD

    Austin, Texas, 78705

  • Arturo Palencia, MD

    Bakersfield, California, 93311

  • Adam Karnes, MD

    Beverly Hills, California, 90211

  • Michael Gibson, MD

    Birmingham, Alabama, 35244

  • Raymond Tidman, MD

    Blue Ridge, Georgia, 30513

  • Patrick Box, MD

    Charlotte, North Carolina, 28210

  • Azazuddin Ahmed, MD

    Chicago, Illinois, 60616

  • Bruce Corser, MD

    Cincinnati, Ohio, 45227

  • Gregory Gottschlich, MD

    Cincinnati, Ohio, 45242

  • Steven Croft, MD

    Delray Beach, Florida, 33484

  • Joseph Dunn, MD

    Eugene, Oregon, 97401

  • Steven Elliott, MD

    Evansville, Indiana, 47714

  • Douglas Haselwood, MD

    Fair Oaks, California, 95628

  • Mel Lucas, MD

    Florissant, Missouri, 63031

  • William Travis Ellison, MD

    Greer, South Carolina, 29651

  • James Meli, DO

    Henderson, Nevada, 89014

  • Roberto Rodriquez, MD

    Hialeah, Florida, 33013

  • Orlando Florete, MD

    Jacksonville, Florida, 32257

  • Michael Link, MD

    Kissimmee, Florida, 34741

  • William Smith, MD

    Knoxville, Tennessee, 37920

  • Miguel Trevino, MD

    Largo, Florida, 33770

  • Stephen Miller, MD

    Las Vegas, Nevada, 89106

  • Vrijendra Kumar, MD

    Las Vegas, Nevada, 89123

  • Arnold Weil

    Marietta, Georgia, 30060

  • Marvin Tark

    Marietta, Georgia, 30066

  • Lee Carter, MD

    Milan, Tennessee, 38358

  • Randale Sechrest, MD

    Missoula, Montana, 59802

  • Arthur Elkind, MD

    Mount Vernon, New York, 10550

  • David Miller, MD

    North Dartmouth, Massachusetts, 02747

  • Tanna Shaw, MD

    Oklahoma City, Oklahoma, 73116

  • John Jacobson, MD

    Omaha, Nebraska, 68134

  • Diego Torres II, MD

    Ormond Beach, Florida, 32174

  • Jenecsis Castro-Skoglund, MD

    Peoria, Illinois, 61614

  • Steven Siwek, MD

    Phoenix, Arizona, 85027

  • Michael Loes, MD

    Phoenix, Arizona, 85032

  • Martin Hale, MD

    Plantation, Florida, 33324

  • Andrew Klymiuk, MD

    Richardson, Texas, 75080

  • Richard Eckert, MD

    Roanoke, Virginia, 24018

  • Rebecca Baumbach, MD

    Saginaw, Michigan, 48602

  • Webster Lynn, MD

    Salt Lake City, Utah, 84106

  • Francis Burch, MD

    San Antonio, Texas, 78217

  • Suzanne Gazda, MD

    San Antonio, Texas, 78229

  • Randall Brewer, MD

    Shreveport, Louisiana, 71103

  • Adnan Dahdul, MD

    Springfield, Massachusetts, 01103

  • Anthony Margherita, MD

    St Louis, Missouri, 63141

  • Margarita Nunez, MD

    St. Petersburg, Florida, 33702

  • Mary Stedman, MD

    Tampa, Florida, 33613

  • Allan Soo, MD

    Tempe, Arizona, 85282

  • Lawrence Levinson, MD

    Tipton, Pennsylvania, 16684

  • Robert Kalb, MD

    Toledo, Ohio, 43623

  • Leah Schmidt, DO

    Tucson, Arizona, 85741

  • Christopher Colopinto, MD

    Voorhees Township, New Jersey, 08043

  • John Peppin, DO

    West Des Moines, Iowa, 50265

  • Richard Rauck, MD

    Winston-Salem, North Carolina, 27103

  • Thomas Littlejohn III, MD

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Conditions
Pain
Being tested
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Keywords
chronic pain, joint pain, back pain, diabetic peripheral neuropathy, post herpetic neuralgia, ALO-01, Embeda, Chronic Non-Malignant Pain
Medical subject headings
Pain, Chronic Pain, Arthralgia, Back Pain, Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)Drug

    Also called Embeda

    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

Study groups in NCT00415597
Study groupRoleWhat they receive
ALO-01ExperimentalDoses given once or twice daily
Receives: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjects With Treatment Emergent Adverse Events

    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).

    Measured: up to 12 months

Secondary outcomes (2)

  1. Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain

    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.

    Measured: 12 weeks

  2. Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain

    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.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415597
Sponsor's protocol ID
ALO-KNT-302
Status last verified
Sep 2013
First submitted
21 Dec 2006
Last updated
20 Sep 2013

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.

    PubMed 26695349

  • Webster LR, Brewer R, Morris D, Cleveland JM, Setnik B. Opioid titration and conversion in patients receiving morphine sulfate and naltrexone hydrochloride extended release capsules. Postgrad Med. 2011 Sep;123(5):155-64. doi: 10.3810/pgm.2011.09.2471.

    PubMed 21904098

  • Webster LR, Brewer R, Wang C, Sekora D, Johnson FK, Morris D, Stauffer J. Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain. J Pain Symptom Manage. 2010 Nov;40(5):734-46. doi: 10.1016/j.jpainsymman.2010.05.004.

    PubMed 21075272

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) in people with Pain, run by Pfizer at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects With Treatment Emergent Adverse Events (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00415597, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.

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