Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

A Phase 3 study of Low Back Pain, run by Purdue Pharma LP at 194 sites in 4 countries.

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 (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy. 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: 455 participants
Where: 194 sitesin 4 countries
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 the past 2 years, with the exception of basal cell carcinoma that has been successfully treated.
Other protocol specific inclusion/exclusion criteria may apply.

Trial locations and contacts

194 sites in 4 countries.

Country

City, postcode or hospital

194 sites in 4 countries

United States170 sites

Investigational Site
Alabaster, Alabama, 35007
Investigational Site
Albuquerque, New Mexico, 87106
Investigational Site
Altoona, Pennsylvania, 16602
Investigational Site
Anaheim, California, 92801
Investigational Site
Anaheim, California, 92804
Investigational Site
Anaheim, California, 92805
Investigational Site
Arlington, Texas, 76011
Investigational Site
Athens, Texas, 75751
Investigational Site
Austell, Georgia, 30106
Investigational Site
Austin, Texas, 78756
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Aventura, Florida, 33180
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Baton Rouge, Louisiana, 70809
Investigational Site
Bay City, Michigan, 48706
Investigational Site
Beavercreek, Ohio, 45432
Investigational Site
Birmingham, Alabama, 35242
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Bloomington, Illinois, 61701
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Blue Ridge, Georgia, 30513
Investigational Site
Boise, Idaho, 83702
Investigational Site
Boynton Beach, Florida, 33472
Investigational Site
Bradenton, Florida, 34209
Investigational Site
Canton, Georgia, 30114
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Cedarhurst, New York, 11516
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Chicago, Illinois, 60657
Investigational Site
Chino, California, 91710
Investigational Site
Cincinnati, Ohio, 45242
Investigational Site
Clearwater, Florida, 33765
Investigational Site
Clermont, Florida, 34711
Investigational Site
Cleveland, Ohio, 44122
Investigational Site
Clinton, Utah, 84015
Investigational Site
Columbus, Georgia, 31904
Investigational Site
Columbus, Ohio, 43210
Investigational Site
Columbus, Ohio, 43214
Investigational Site
Coral Gables, Florida, 33134
Investigational Site
Covington, Louisiana, 70435
Investigational Site
Dallas, Texas, 75231
Investigational Site
Dallas, Texas, 75251
Investigational Site
Daytona Beach, Florida, 32117
Investigational Site
Elkin, North Carolina, 28621
Investigational Site
Evansville, Indiana, 47714
Investigational Site
Fall River, Massachusetts, 02720
Investigational Site
Fort Lauderdale, Florida, 33316
Investigational Site
Franklin, Ohio, 45005
Investigational Site
Franklin, Tennessee, 37067
Investigational Site
Fresno, California, 93720
Investigational Site
Fresno, California, 93726
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Glendale, California, 91206
Investigational Site
Golden, Colorado, 80401
Investigational Site
Goodyear, Arizona, 85395-2511
Investigational Site
Goodyear, Arizona, 85395
Investigational Site
Great Neck, New York, 11023
Investigational Site
Groveport, Ohio, 43125
Investigational Site
Gulf Shores, Alabama, 36542
Investigational Site
Hazelwood, Missouri, 63042
Investigational Site
Hialeah, Florida, 33012
Investigational Site
Hialeah, Florida, 33013
Investigational Site
Hollywood, Maryland, 20636
Investigational Site
Homewood, Alabama, 35209
Investigational Site
Hot Springs, Arkansas, 71901
Investigational Site
Houston, Texas, 77005
Investigational Site
Houston, Texas, 77024
Investigational Site
Houston, Texas, 77025
Investigational Site
Houston, Texas, 77030
Investigational Site
Houston, Texas, 77057
Investigational Site
Houston, Texas, 77065
Investigational Site
Houston, Texas, 77074
Investigational Site
Houston, Texas, 77098
Investigational Site
Humble, Texas, 77338
Investigational Site
Huntsville, Alabama, 35801
Investigational Site
Inverness, Florida, 34452
Investigational Site
Jacksonville, Florida, 32216
Investigational Site
Jacksonville, Florida, 32257
Investigational Site
Jenkintown, Pennsylvania, 19046
Investigational Site
Johns Creek, Georgia, 30097
Investigational Site
Johnstown, Pennsylvania, 15904
Investigational Site
Jupiter, Florida, 33458
Investigational Site
Kansas City, Kansas, 66160
Investigational Site
La Mesa, California, 91942
Investigational Site
Laguna Hills, California, 92637
Investigational Site
Las Vegas, Nevada, 89119
Investigational Site
Lexington, Kentucky, 40504
Investigational Site
Little Rock, Arkansas, 72211
Investigational Site
Long Beach, California, 90806
Investigational Site
Los Angeles, California, 90017
Investigational Site
Los Angeles, California, 90025
Investigational Site
Los Angeles, California, 90036
Investigational Site
Los Gatos, California, 95032
Investigational Site
Madisonville, Kentucky, 42431
Investigational Site
Marietta, Georgia, 30060
Investigational Site
Marrero, Louisiana, 70072
Investigational Site
Meridian, Idaho, 83642
Investigational Site
Metairie, Louisiana, 70006
Investigational Site
Miami, Florida, 33125
Investigational Site
Miami, Florida, 33126
Investigational Site
Miami, Florida, 33135
Investigational Site
Miami, Florida, 33143
Investigational Site
Miami, Florida, 33185
Investigational Site
Miami Lakes, Florida, 33014
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Mobile, Alabama, 36608
Investigational Site
Myrtle Beach, South Carolina, 29588
Investigational Site
Naples, Florida, 34110
Investigational Site
Naples, Florida, 34113
Investigational Site
National City, California, 91950
Investigational Site
New Haven, Connecticut, 06511
Investigational Site
New Port Richey, Florida, 34652
Investigational Site
New Tazewell, Tennessee, 37825
Investigational Site
New Windsor, New York, 12553
Investigational Site
New York, New York, 10022
Investigational Site
North Attleboro, Massachusetts, 02760
Investigational Site
North Hollywood, California, 91606
Investigational Site
North Massapequa, New York, 11758
Investigational Site
North Miami Beach, Florida, 33162
Investigational Site
North Richland Hills, Texas, 76180
Investigational Site
Oceanside, California, 92056
Investigational Site
Oklahoma City, Oklahoma, 73119
Investigational Site
Orlando, Florida, 32806
Investigational Site
Oviedo, Florida, 32765
Investigational Site
Paramount, California, 90723
Investigational Site
Perry, Georgia, 31069
Investigational Site
Philadelphia, Pennsylvania, 19152
Investigational Site
Phoenix, Arizona, 85018
Investigational Site
Phoenix, Arizona, 85027
Investigational Site
Phoenixville, Pennsylvania, 19460
Investigational Site
Pinconning, Michigan, 48650
Investigational Site
Pinellas Park, Florida, 33781
Investigational Site
Pinellas Park, Florida, 33782
Investigational Site
Plano, Texas, 75075
Investigational Site
Plantation, Florida, 33317
Investigational Site
Port Orange, Florida, 32129
Investigational Site
Richmond, California, 94806
Investigational Site
Richmond, Virginia, 23220
Investigational Site
Richmond, Virginia, 23235
Investigational Site
Rochester, Michigan, 48307
Investigational Site
Roseville, California, 95661
Investigational Site
Sacramento, California, 95823
Investigational Site
Sacramento, California, 95842
Investigational Site
Salt Lake City, Utah, 84102
Investigational Site
Salt Lake City, Utah, 84107
Investigational Site
San Antonio, Texas, 78229
Investigational Site
San Antonio, Texas, 78238
Investigational Site
San Diego, California, 92114
Investigational Site
Sanford, Florida, 32771
Investigational Site
Santa Ana, California, 92701
Investigational Site
Santa Clarita, California, 91350
Investigational Site
Savannah, Georgia, 31405
Investigational Site
South Miami, Florida, 33143
Investigational Site
Spartanburg, South Carolina, 29303
Investigational Site
St Louis, Missouri, 63128
Investigational Site
St Louis, Missouri, 63141
Investigational Site
Stratford, New Jersey, 08084
Investigational Site
Sugar Land, Texas, 77478
Investigational Site
Tamarac, Florida, 33321
Investigational Site
Tampa, Florida, 33607
Investigational Site
Tampa, Florida, 33613
Investigational Site
Tempe, Arizona, 85282
Investigational Site
Tipton, Pennsylvania, 16684
Investigational Site
Toledo, Ohio, 43623
Investigational Site
Tomball, Texas, 77375
Investigational Site
Toms River, New Jersey, 08755
Investigational Site
Troy, Michigan, 48085
Investigational Site
Tucson, Arizona, 85704
Investigational Site
Valley Village, California, 91607
Investigational Site
Virginia Beach, Virginia, 23454
Investigational Site
Voorhees Township, New Jersey, 08034
Investigational Site
Warwick, Rhode Island, 02886
Investigational Site
Waterbury, Connecticut, 06708
Investigational Site
Wellington, Florida, 33414
Investigational Site
West Jordan, Utah, 84088
Investigational Site
Wichita, Kansas, 67203
Investigational Site
Williamsville, New York, 14221
Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Czechia12 sites

Investigational Site
Brno, 656 91
Investigational Site
Hradec Králové, 500 03
Investigational Site
Most, 434 64
Investigational Site
Olomouc, 775 20
Investigational Site
Prague, 100 00
Investigational Site
Prague, 160 00
Investigational Site
Praha 4 - Krc, 140 59
Investigational Site
Rychnov nad Kněžnou, 516 01
Investigational Site
Sternberk, 785 01
Investigational Site
Vysoké Mýto, 566 23
Investigational Site
Zlín, 760 01
Investigational Site
Znojmo, 669 02

Other trials in Czechia

Poland11 sites

Investigational Site
Bielsko-Biala, 43-300
Investigational Site
Bydgoszcz, 85-079
Investigational Site
Bydgoszcz, 85-796
Investigational Site
Gdansk, 80-286
Investigational Site
Gdansk, 80-546
Investigational Site
Gdynia, 81-366
Investigational Site
Katowice, 40-084
Investigational Site
Katowice, 40-683
Investigational Site
Lublin, 20-582
Investigational Site
Lublin, 20-718
Investigational Site
Torun, 87-100

Other trials in Poland

Italy1 site

Investigational Site
Catania, 95123

Other trials in Italy

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 Uncontrolled 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 chronic low back pain
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 NCT01427270
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: 455 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01427270
Sponsor's protocol ID: ONU3704
Other IDs: 2011-005060-26
Status last verified: Nov 2014
First submitted: 30 Aug 2011
Last updated: 7 Nov 2014
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 Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2014. 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 Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
ClinicalTrials.gov ID: NCT01427270
Acronym / sponsor ID: ONU3704
Conditions: Low Back Pain
Keywords: Low back pain, Chronic pain, Opioid, Constipation, Moderate to severe chronic low back pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 455 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 7 Nov 2014.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

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.

194 sites in 4 countries: 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 194 sites in 4 countries.

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 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in United States, Czechia, Poland, Italy. 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 NCT01427270.

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 7 Nov 2014.