OsteoarthritisPhase 3NCT00420992

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

A Phase 3 study testing ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) in people with Osteoarthritis and Chronic Pain, run by Pfizer at 81 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

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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Osteoarthritis, Chronic Pain
What is being tested?: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 547 participants
Where: 81 sitesUnited States
Study dates: Dec 2006to Nov 2007
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

81 sites in 1 country.

City, postcode or hospital

81 sites in 1 country

United States81 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Osteoarthritis, Chronic Pain
Being tested: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release), Placebo
Keywords: hip, knee, pain, osteoarthritis, OA, Kadian, Alpharma, naltrexone, Opioid, morphine, Embeda, ALO-01
Medical subject headings: Osteoarthritis, Chronic Pain, Pain

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 Extended Release)Drug
Also called Embeda
capsules, up to 80 mg bid
PlaceboDrug
capsules, bid

Study groups in NCT00420992
Study group	Role	What they receive
ALO-01	Experimental	Up to 80 mg twice a day (bid) Receives: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
Placebo	Placebo comparator	Twice a day (bid) Receives: Drug: Placebo

What is being measured

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

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)
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
Measured: randomization to 12 weeks following randomization

Timeline

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

Dec 2006Nov 2007

First posted11 Jan 2007 (estimated)
Study startDec 2006
Primary completionNov 2007
Study completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 547 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00420992
Sponsor's protocol ID: ALO-KNT-301
Status last verified: Sep 2013
First submitted: 10 Jan 2007
Last updated: 20 Sep 2013
Results posted: Yes, on ClinicalTrials.gov

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00420992
Acronym / sponsor ID: ALO-KNT-301
Conditions: Osteoarthritis, Chronic Pain
Keywords: hip, knee, pain, osteoarthritis, OA, Kadian, Alpharma, naltrexone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 547 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 11 Jan 2007 (estimated)
Results: Posted 30 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ALO-01	Experimental	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)Up to 80 mg twice a day (bid)
Placebo	Placebo comparator	Drug: PlaceboTwice a day (bid)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)Also: Embedacapsules, up to 80 mg bid	Drug	ALO-01
Placebocapsules, bid	Drug	Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 30 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ALO-01	547	344
Placebo	0	0

Primary outcome: 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. Mean (Standard Deviation). Unit: units on scale

Measure	ALO-01 n = 170	Placebo n = 173
Value	-0.2 (1.94)	0.3 (2.05)

ALO-01 vs Placebo: p = 0.0445, ANCOVA

Population analysed: intent to treat (ITT)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALO-01	6 of 171 (3.5%)	54 of 171 (31.6%)	Not reported
Placebo	3 of 173 (1.7%)	48 of 173 (27.7%)	Not reported
Titration ALO-01	3 of 547 (0.5%)	301 of 547 (55%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26695349Setnik 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.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James B. Jones, MD, PharmD study director

Alpharma Pharmceuticals

81 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) in people with Osteoarthritis and Chronic Pain, run by Pfizer at 81 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 6 inclusion and 8 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 81 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. Some participants in this study may receive a placebo. 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 30 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?

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). 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 NCT00420992, which also lists 1 linked publication.

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.