A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

A Phase 3 study of Low Back Pain, run by Purdue Pharma LP at 149 sites in United States.

Completed

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

Trial summary

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 450 participants
Where: 149 sitesUnited States
Study dates: Aug 2011to Oct 2014
Phase: Phase 3
Are there results?: None posted in the registry

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

Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
Subjects must have a self-reported history of opioid induced constipation (OIC).

Who cannot join

Subjects with rheumatoid arthritis or other inflammatory arthritis;
Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
Subjects with chronic constipation not related to opioid use;
Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.
Other protocol specific inclusion/exclusion criteria may apply.

Trial locations and contacts

149 sites in 1 country.

City, postcode or hospital

149 sites in 1 country

United States149 sites

Investigational Site
Alabaster, Alabama, 35007
Investigational Site
Allen, Texas, 75013
Investigational Site
Anaheim, California, 92801
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Anaheim, California, 92804
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Artesia, California, 90701
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Atco, New Jersey, 08004
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Atlanta, Georgia, 30308
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Austell, Georgia, 30106
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Austin, Texas, 78731
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Aventura, Florida, 33180
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Birmingham, Alabama, 35213
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Birmingham, Alabama, 35216
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Boise, Idaho, 83704
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Boise, Idaho, 83713
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Bothell, Washington, 98011
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Bradenton, Florida, 34209
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Brockton, Massachusetts, 02301
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Cerritos, California, 90703
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Charleston, South Carolina, 29406
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Chicago, Illinois, 60616
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Chicago, Illinois, 60622
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Chicago, Illinois, 60657
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Chiefland, Florida, 32626
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Chino, California, 91710
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Clermont, Florida, 34711
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80909
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Columbus, Ohio, 43213
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Dallas, Texas, 75203
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Dallas, Texas, 75218
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Dallas, Texas, 75231
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Dallas, Texas, 75251
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Danville, Virginia, 24541
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Dayton, Ohio, 45406
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Daytona Beach, Florida, 32117
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DeLand, Florida, 32720
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Denver, Colorado, 80246
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Durham, North Carolina, 27710
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Edgewater, Florida, 32132
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Edgewood, Kentucky, 41017
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El Cajon, California, 92020
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Elkin, North Carolina, 28621
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Encino, California, 91436
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Eugene, Oregon, 97404
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Evansville, Indiana, 47714
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Florissant, Missouri, 63031
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Foley, Alabama, 36535
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Fort Lauderdale, Florida, 33316
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Fort Myers, Florida, 33916
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Fountain Valley, California, 92708
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Fresno, California, 93720
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Garden Grove, California, 92843
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Garden Grove, California, 92844
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Golden, Colorado, 80401
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Great Neck, New York, 11023
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Hialeah, Florida, 33010
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Hialeah, Florida, 33012
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High Point, North Carolina, 27262
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Houston, Texas, 77062
Investigational Site
Houston, Texas, 77065
Investigational Site
Houston, Texas, 77074
Investigational Site
Houston, Texas, 77098
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Indianapolis, Indiana, 46250
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Inverness, Florida, 34452
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32216
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Jacksonville, Florida, 32256
Investigational Site
Jacksonville, Florida, 32257
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Jenkintown, Pennsylvania, 19046
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Kew Gardens, New York, 11415
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Laguna Hills, California, 92653
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Lake Charles, Louisiana, 70601
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Lakewood, California, 90712
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Las Vegas, Nevada, 89119
Investigational Site
Levittown, Pennsylvania, 19056
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Lincoln, California, 95648
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Little Rock, Arkansas, 72211
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Lomita, California, 90717
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Long Beach, California, 90806
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McKinney, Texas, 75070
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Mechanicsburg, Pennsylvania, 17055
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Mesa, Arizona, 85202
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Miami, Florida, 33015
Investigational Site
Miami, Florida, 33125
Investigational Site
Miami, Florida, 33126
Investigational Site
Miami, Florida, 33135
Investigational Site
Miami, Florida, 33136
Investigational Site
Miami, Florida, 33144
Investigational Site
Miami, Florida, 33145
Investigational Site
Miami, Florida, 33155
Investigational Site
Miami, Florida, 33165
Investigational Site
Miami, Florida, 33185
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Miami Beach, Florida, 33140
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Michigan City, Indiana, 46360
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Midlothian, Virginia, 23114
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Mobile, Alabama, 36608
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Monroe, Louisiana, 71201
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Moraine, Ohio, 45439
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Myrtle Beach, South Carolina, 29588
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Naples, Florida, 34110
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Naples, Florida, 34113
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New Orleans, Louisiana, 70119
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New Smyrna Beach, Florida, 32168
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New York, New York, 10023
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North Miami, Florida, 33161
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North Richland Hills, Texas, 76180
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Oceanside, California, 92054
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Oklahoma City, Oklahoma, 73103
Investigational Site
Oklahoma City, Oklahoma, 73109
Investigational Site
Oklahoma City, Oklahoma, 73119
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Oldsmar, Florida, 34677
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Orange, California, 92868
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Orem, Utah, 84058
Investigational Site
Orlando, Florida, 32806
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Oviedo, Florida, 32765
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Paramount, California, 90723
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Phoenix, Arizona, 85020
Investigational Site
Phoenix, Arizona, 85021
Investigational Site
Pikesville, Maryland, 21208
Investigational Site
Pittsburgh, Pennsylvania, 15215
Investigational Site
Plantation, Florida, 33317
Investigational Site
Rapid City, South Dakota, 57702
Investigational Site
Red Lion, Pennsylvania, 17356
Investigational Site
Richmond, Virginia, 23220
Investigational Site
Rochester, New York, 14618
Investigational Site
Sacramento, California, 95823
Investigational Site
Salt Lake City, Utah, 84102
Investigational Site
Salt Lake City, Utah, 84124
Investigational Site
San Bernardino, California, 92408
Investigational Site
San Diego, California, 92103
Investigational Site
San Diego, California, 92114
Investigational Site
Sherwood, Arkansas, 72120
Investigational Site
Snellville, Georgia, 30078
Investigational Site
State College, Pennsylvania, 16801
Investigational Site
Sun Lakes, Arizona, 85248
Investigational Site
Tamarac, Florida, 33321
Investigational Site
Tampa, Florida, 33607
Investigational Site
Thousand Oaks, California, 91360
Investigational Site
Toledo, Ohio, 43614
Investigational Site
Tomball, Texas, 77375
Investigational Site
Torrance, California, 90509
Investigational Site
Tucson, Arizona, 85704
Investigational Site
Tucson, Arizona, 85712
Investigational Site
Warwick, Rhode Island, 02886
Investigational Site
West Palm Beach, Florida, 33409
Investigational Site
Wichita, Kansas, 67203
Investigational Site
Williamsville, New York, 14221
Investigational Site
Winston-Salem, North Carolina, 27103
Investigational Site
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy

Conditions: Low Back Pain
Being tested: Oxycodone/Naloxone controlled-release, Oxycodone HCl controlled-release, Placebo
Keywords: Low back pain, Chronic pain, Opioid, Constipation, Moderate to severe
Medical subject headings: Low Back Pain, Chronic Pain, Constipation

What participants receive

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

Oxycodone/Naloxone controlled-releaseDrug
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
Oxycodone HCl controlled-releaseDrug
Also called OxyContin
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
PlaceboDrug
Placebo tablets to match OXN or OXY taken orally every 12 hours

Study groups in NCT01427283
Study group	Role	What they receive
OXN	Experimental	Oxycodone/Naloxone controlled-release tablets (OXN) Receives: Drug: Oxycodone/Naloxone controlled-release
OXY	Active comparator	Oxycodone HCl controlled-release tablets (OXY) Receives: Drug: Oxycodone HCl controlled-release
Placebo	Placebo comparator	Placebo tablets to match OXN or OXY Receives: Drug: Placebo

What is being measured

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

Overall complete spontaneous bowel movement (CSBM) responder rates
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
Measured: Weeks 1 through 12

Secondary outcomes (2)

CSBM Responder at least 50% of the weeks in the double-blind period
Measured: Weeks 1 through 12
Laxative-free Responder at least 50% of the weeks in the double-blind period
Measured: Weeks 1 through 12

Timeline

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

Aug 2011Oct 2014

First posted1 Sep 2011 (estimated)
Study startAug 2011
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
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: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01427283
Sponsor's protocol ID: ONU3705
Other IDs: 2011-005061-20
Status last verified: Feb 2015
First submitted: 30 Aug 2011
Last updated: 12 Feb 2015
Results posted: No
Data monitoring committee: No

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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Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
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Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
ClinicalTrials.gov ID: NCT01427283
Acronym / sponsor ID: ONU3705
Conditions: Low Back Pain
Keywords: Low back pain, Chronic pain, Opioid, Constipation, Moderate to severe
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 1 Sep 2011 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
OXN	Experimental	Drug: Oxycodone/Naloxone controlled-releaseOxycodone/Naloxone controlled-release tablets (OXN)
OXY	Active comparator	Drug: Oxycodone HCl controlled-releaseOxycodone HCl controlled-release tablets (OXY)
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets to match OXN or OXY

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
Subjects must have a self-reported history of opioid induced constipation (OIC).

Key exclusion criteria (7 listed)

Subjects with rheumatoid arthritis or other inflammatory arthritis;
Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
Subjects with chronic constipation not related to opioid use;
Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;

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
Oxycodone/Naloxone controlled-releaseOxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours	Drug	OXN
Oxycodone HCl controlled-releaseAlso: OxyContinOxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours	Drug	OXY
PlaceboPlacebo tablets to match OXN or OXY taken orally every 12 hours	Drug	Placebo

Primary outcome

Overall complete spontaneous bowel movement (CSBM) responder rates
Time frame: Weeks 1 through 12
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY

2 secondary outcomes

CSBM Responder at least 50% of the weeks in the double-blind period
Time frame: Weeks 1 through 12
Laxative-free Responder at least 50% of the weeks in the double-blind period
Time frame: Weeks 1 through 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.

Related trials for Low Back Pain

Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Low Back Pain, run by Purdue Pharma LP at 149 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 7 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall complete spontaneous bowel movement (CSBM) responder rates (time frame: Weeks 1 through 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 NCT01427283.

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 12 Feb 2015.