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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01428583

Public ClinicalTrials.gov record NCT01428583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01428583
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
395 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2010 (Type not available)
Primary completion
May 2012 (Actual)
Completion
May 2012 (Actual)
Last update posted
Nov 21, 2016

2010 – 2012

United States locations

U.S. sites
32
U.S. states
17
U.S. cities
30
Facility City State ZIP Site status
Avail Clinical Research, LLC DeLand Florida 32720 —
Florida Institute of Medical Research Jacksonville Florida 32257 —
Drug Study Institute Jupiter Florida 33458 —
Ormond Medical Arts Pharmaceutical Research Center Ormond Beach Florida 32174 —
Peninsula Research, Inc. Ormond Beach Florida 32174 —
Accord Clinical Research Port Orange Florida 32129 —
Sarasota Pain Medicine Research Sarasota Florida 34238 —
Clinical Research of West Florida Tampa Florida 33603 —
Center for Prospective Outcome Studies, Inc. Atlanta Georgia 30327 —
Drug Studies America Marietta Georgia 30060 —
Georgia Institute for Clinical Research, LLC Marietta Georgia 30060 —
The Pain Treatment Center of the Bluegrass Lexington Kentucky 40503 —
Commonwealth Biomedical Research Madisonville Kentucky 42431 —
Crossroads Research Owings Mills Maryland 21117 —
DM Clinical Research Springfield Massachusetts 01103 —
MAPS Applied Research Center Edina Minnesota 55435 —
Mid-South Anesthesia Consultants Southaven Mississippi 38671 —
Healthcare Research, LLC Hazelwood Missouri 64042 —
Montana Neuroscience Institute Missoula Montana 59802 —
Comprehensive Clinical Research Berlin New Jersey 08009 —
Drug Trials America - New York Hartsdale New York 10530 —
New York Spine and Wellness Center North Syracuse New York 13212 —
Upstate Clinical Research Associates Williamsville New York 14221 —
Center for Clinical Research, LLC - Winston-Salem Winston-Salem North Carolina 27103 —
Columbus Clinical Research, Inc. Columbus Ohio 43213 —
Allegheny Pain Management, PC Altoona Pennsylvania 16602 —
FutureSearch Trials of Neurology Austin Texas 78731 —
KRK Medical Research Dallas Texas 75230 —
Benchmark Research - Fort Worth Fort Worth Texas 76135 —
Quality Research, Inc. San Antonio Texas 78209 —
Lifetree Clinical Research Salt Lake City Utah 84106 —
Hypothetest, LLC Roanoke Virginia 24018 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01428583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 21, 2016 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01428583 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →