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Chronic Noncancer PainPhase 3NCT01428583

Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

A Phase 3 study testing oxycodone HCl and naltrexone HCl extended-release capsules in people with Chronic Noncancer Pain, run by Pfizer at 32 sites in United States.

Completed

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

Official record
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Trial summary

The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Noncancer Pain
What is being tested?
oxycodone HCl and naltrexone HCl extended-release capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
395 participants
Where
32 sitesUnited States
Study dates
Dec 2010to May 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
  • Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)

Who cannot join

  • Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
  • Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
  • Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
  • Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
  • Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
  • If female, the subject is pregnant or breast-feeding.
  • Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
  • Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Allegheny Pain Management, PC

    Altoona, Pennsylvania, 16602

  • Center for Prospective Outcome Studies, Inc.

    Atlanta, Georgia, 30327

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Columbus Clinical Research, Inc.

    Columbus, Ohio, 43213

  • KRK Medical Research

    Dallas, Texas, 75230

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • MAPS Applied Research Center

    Edina, Minnesota, 55435

  • Benchmark Research - Fort Worth

    Fort Worth, Texas, 76135

  • Drug Trials America - New York

    Hartsdale, New York, 10530

  • Healthcare Research, LLC

    Hazelwood, Missouri, 64042

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • Drug Study Institute

    Jupiter, Florida, 33458

  • The Pain Treatment Center of the Bluegrass

    Lexington, Kentucky, 40503

  • Commonwealth Biomedical Research

    Madisonville, Kentucky, 42431

  • Drug Studies America

    Marietta, Georgia, 30060

  • Georgia Institute for Clinical Research, LLC

    Marietta, Georgia, 30060

  • Montana Neuroscience Institute

    Missoula, Montana, 59802

  • New York Spine and Wellness Center

    North Syracuse, New York, 13212

  • Ormond Medical Arts Pharmaceutical Research Center

    Ormond Beach, Florida, 32174

  • Peninsula Research, Inc.

    Ormond Beach, Florida, 32174

  • Crossroads Research

    Owings Mills, Maryland, 21117

  • Accord Clinical Research

    Port Orange, Florida, 32129

  • Hypothetest, LLC

    Roanoke, Virginia, 24018

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • Quality Research, Inc.

    San Antonio, Texas, 78209

  • Sarasota Pain Medicine Research

    Sarasota, Florida, 34238

  • Mid-South Anesthesia Consultants

    Southaven, Mississippi, 38671

  • DM Clinical Research

    Springfield, Massachusetts, 01103

  • Clinical Research of West Florida

    Tampa, Florida, 33603

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • Center for Clinical Research, LLC - Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain

The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.

Being tested
oxycodone HCl and naltrexone HCl extended-release capsules
Keywords
Chronic noncancer pain, oxycodone, naltrexone

What participants receive

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

  • oxycodone HCl and naltrexone HCl extended-release capsulesDrug

    Also called ALO-02

    Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)

Study groups in NCT01428583
Study groupRoleWhat they receive
oxycodone HCl and naltrexone HCl extended-release capsulesExperimentalNot described
Receives: Drug: oxycodone HCl and naltrexone HCl extended-release capsules

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.

    Measured: Baseline up to end of study (2 weeks post-end of month 12)

Secondary outcomes (3)

  1. Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.

    Measured: Baseline up to end of study (2 weeks post-end of month 12)

  2. Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score

    The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.

    Measured: Baseline up to Month 12

  3. Subjective Opiate Withdrawal Scale (SOWS) Score

    The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.

    Measured: Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Timeline

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

  1. First posted5 Sep 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionMay 2012
  4. Study completionMay 2012

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
Supportive care
Masking
None (open label)
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01428583
Sponsor's protocol ID
ALO-02-10-3001
Other IDs
B4531001
Status last verified
Jun 2016
First submitted
2 Sep 2011
Last updated
21 Nov 2016
Data monitoring committee
No

Publications

  • Gimbel JS, Rauck RL, Bass A, Wilson J, Pixton G, Malhotra B, Wilson G, Wolfram G. Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. J Opioid Manag. 2019 Sep/Oct;15(5):417-427. doi: 10.5055/jom.2019.0530.

    PubMed 31849032

  • Wilson JG, Bass A, Pixton GC, Wolfram G, Rauck RL. Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.

    PubMed 31456431

  • Arora S, Setnik B, Michael D, Hudson JD, Clemmer R, Meisner P, Pixton GC, Goli V, Sommerville KW. A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain. J Opioid Manag. 2014 Nov-Dec;10(6):423-36. doi: 10.5055/jom.2014.0239.

    PubMed 25531960

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing oxycodone HCl and naltrexone HCl extended-release capsules in people with Chronic Noncancer Pain, run by Pfizer at 32 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 2 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 21 Nov 2016). 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?

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions (time frame: Baseline up to end of study (2 weeks post-end of month 12)). 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 NCT01428583, 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 21 Nov 2016.

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