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
Sponsor
Purdue Pharma LP (Industry)
Overall Status
Completed
CT.gov ID
NCT01427283
Collaborator
(none)
450
150
3
38
3
0.1
Study Details
Study Description
Brief 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 around-the-clock opioid therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date
:
Aug 1, 2011
Actual Primary Completion Date
:
Oct 1, 2014
Actual Study Completion Date
:
Oct 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OXN Oxycodone/Naloxone controlled-release tablets (OXN) |
Drug: Oxycodone/Naloxone controlled-release
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
|
| Active Comparator: OXY Oxycodone HCl controlled-release tablets (OXY) |
Drug: Oxycodone HCl controlled-release
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
Other Names:
|
| Placebo Comparator: Placebo Placebo tablets to match OXN or OXY |
Drug: Placebo
Placebo tablets to match OXN or OXY taken orally every 12 hours
|
Outcome Measures
Primary Outcome Measures
- Overall complete spontaneous bowel movement (CSBM) responder rates [Weeks 1 through 12]
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
Secondary Outcome Measures
- CSBM Responder at least 50% of the weeks in the double-blind period [Weeks 1 through 12]
- Laxative-free Responder at least 50% of the weeks in the double-blind period [Weeks 1 through 12]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria include:
-
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).
Exclusion Criteria include:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site | Alabaster | Alabama | United States | 35007 |
| 2 | Investigational Site | Birmingham | Alabama | United States | 35213 |
| 3 | Investigational Site | Birmingham | Alabama | United States | 35216 |
| 4 | Investigational Site | Foley | Alabama | United States | 36535 |
| 5 | Investigational Site | Mobile | Alabama | United States | 36608 |
| 6 | Investigational Site | Mesa | Arizona | United States | 85202 |
| 7 | Investigational Site | Phoenix | Arizona | United States | 85020 |
| 8 | Investigational Site | Phoenix | Arizona | United States | 85021 |
| 9 | Investigational Site | Sun Lakes | Arizona | United States | 85248 |
| 10 | Investigational Site | Tucson | Arizona | United States | 85704 |
| 11 | Investigational Site | Tucson | Arizona | United States | 85712 |
| 12 | Investigational Site | Little Rock | Arkansas | United States | 72211 |
| 13 | Investigational Site | Sherwood | Arkansas | United States | 72120 |
| 14 | Investigational Site | Anaheim | California | United States | 92801 |
| 15 | Investigational Site | Anaheim | California | United States | 92804 |
| 16 | Investigational Site | Artesia | California | United States | 90701 |
| 17 | Investigational Site | Cerritos | California | United States | 90703 |
| 18 | Investigational Site | Chino | California | United States | 91710 |
| 19 | Investigational Site | El Cajon | California | United States | 92020 |
| 20 | Investigational Site | Encino | California | United States | 91436 |
| 21 | Investigational Site | Fountain Valley | California | United States | 92708 |
| 22 | Investigational Site | Fresno | California | United States | 93720 |
| 23 | Investigational Site | Garden Grove | California | United States | 92843 |
| 24 | Investigational Site | Garden Grove | California | United States | 92844 |
| 25 | Investigational Site | Laguna Hills | California | United States | 92653 |
| 26 | Investigational Site | Lakewood | California | United States | 90712 |
| 27 | Investigational Site | Lincoln | California | United States | 95648 |
| 28 | Investigational Site | Lomita | California | United States | 90717 |
| 29 | Investigational Site | Long Beach | California | United States | 90806 |
| 30 | Investigational Site | Oceanside | California | United States | 92054 |
| 31 | Investigational Site | Orange | California | United States | 92868 |
| 32 | Investigational Site | Paramount | California | United States | 90723 |
| 33 | Investigational Site | Sacramento | California | United States | 95823 |
| 34 | Investigational Site | San Bernardino | California | United States | 92408 |
| 35 | Investigational Site | San Diego | California | United States | 92103 |
| 36 | Investigational Site | San Diego | California | United States | 92114 |
| 37 | Investigational Site | Thousand Oaks | California | United States | 91360 |
| 38 | Investigational Site | Torrance | California | United States | 90509 |
| 39 | Investigational Site | Colorado Springs | Colorado | United States | 80907 |
| 40 | Investigational Site | Colorado Springs | Colorado | United States | 80909 |
| 41 | Investigational Site | Denver | Colorado | United States | 80246 |
| 42 | Investigational Site | Golden | Colorado | United States | 80401 |
| 43 | Investigational Site | Aventura | Florida | United States | 33180 |
| 44 | Investigational Site | Bradenton | Florida | United States | 34209 |
| 45 | Investigational Site | Chiefland | Florida | United States | 32626 |
| 46 | Investigational Site | Clermont | Florida | United States | 34711 |
| 47 | Investigational Site | Daytona Beach | Florida | United States | 32117 |
| 48 | Investigational Site | Deland | Florida | United States | 32720 |
| 49 | Investigational Site | Edgewater | Florida | United States | 32132 |
| 50 | Investigational Site | Ft. Lauderdale | Florida | United States | 33316 |
| 51 | Investigational Site | Ft. Myers | Florida | United States | 33916 |
| 52 | Investigational Site | Hialeah | Florida | United States | 33010 |
| 53 | Investigational Site | Hialeah | Florida | United States | 33012 |
| 54 | Investigational Site | Inverness | Florida | United States | 34452 |
| 55 | Investigational Site | Jacksonville | Florida | United States | 32216 |
| 56 | Investigational Site | Jacksonville | Florida | United States | 32256 |
| 57 | Investigational Site | Jacksonville | Florida | United States | 32257 |
| 58 | Investigational Site | Miami Beach | Florida | United States | 33140 |
| 59 | Investigational Site | Miami | Florida | United States | 33015 |
| 60 | Investigational Site | Miami | Florida | United States | 33125 |
| 61 | Investigational Site | Miami | Florida | United States | 33126 |
| 62 | Investigational Site | Miami | Florida | United States | 33135 |
| 63 | Investigational Site | Miami | Florida | United States | 33136 |
| 64 | Investigational Site | Miami | Florida | United States | 33144 |
| 65 | Investigational Site | Miami | Florida | United States | 33145 |
| 66 | Investigational Site | Miami | Florida | United States | 33155 |
| 67 | Investigational Site | Miami | Florida | United States | 33165 |
| 68 | Investigational Site | Miami | Florida | United States | 33185 |
| 69 | Investigational Site | Naples | Florida | United States | 34110 |
| 70 | Investigational Site | Naples | Florida | United States | 34113 |
| 71 | Investigational Site | New Smyrna Beach | Florida | United States | 32168 |
| 72 | Investigational Site | North Miami | Florida | United States | 33161 |
| 73 | Investigational Site | Oldsmar | Florida | United States | 34677 |
| 74 | Investigational Site | Orlando | Florida | United States | 32806 |
| 75 | Investigational Site | Oviedo | Florida | United States | 32765 |
| 76 | Investigational Site | Plantation | Florida | United States | 33317 |
| 77 | Investigational Site | Tamarac | Florida | United States | 33321 |
| 78 | Investigational Site | Tampa | Florida | United States | 33607 |
| 79 | Investigational Site | West Palm Beach | Florida | United States | 33409 |
| 80 | Investigational Site | Atlanta | Georgia | United States | 30308 |
| 81 | Investigational Site | Austell | Georgia | United States | 30106 |
| 82 | Investigational Site | Snellville | Georgia | United States | 30078 |
| 83 | Investigational Site | Boise | Idaho | United States | 83704 |
| 84 | Investigational Site | Boise | Idaho | United States | 83713 |
| 85 | Investigational Site | Chicago | Illinois | United States | 60616 |
| 86 | Investigational Site | Chicago | Illinois | United States | 60622 |
| 87 | Investigational Site | Chicago | Illinois | United States | 60657 |
| 88 | Investigational Site | Evansville | Indiana | United States | 47714 |
| 89 | Investigational Site | Indianapolis | Indiana | United States | 46250 |
| 90 | Investigational Site | Michigan City | Indiana | United States | 46360 |
| 91 | Investigational Site | Wichita | Kansas | United States | 67203 |
| 92 | Investigational Site | Edgewood | Kentucky | United States | 41017 |
| 93 | Investigational Site | Lake Charles | Louisiana | United States | 70601 |
| 94 | Investigational Site | Monroe | Louisiana | United States | 71201 |
| 95 | Investigational Site | New Orleans | Louisiana | United States | 70119 |
| 96 | Investigational Site | Pikesville | Maryland | United States | 21208 |
| 97 | Investigational Site | Brockton | Massachusetts | United States | 02301 |
| 98 | Investigational Site | Worcester | Massachusetts | United States | 01605 |
| 99 | Investigational Site | Florissant | Missouri | United States | 63031 |
| 100 | Investigational Site | Las Vegas | Nevada | United States | 89119 |
| 101 | Investigational Site | Atco | New Jersey | United States | 08004 |
| 102 | Investigational Site | Great Neck | New York | United States | 11023 |
| 103 | Investigational Site | Kew Gardens | New York | United States | 11415 |
| 104 | Investigational Site | New York | New York | United States | 10023 |
| 105 | Investigational Site | Rochester | New York | United States | 14618 |
| 106 | Investigational Site | Williamsville | New York | United States | 14221 |
| 107 | Investigational Site | Durham | North Carolina | United States | 27710 |
| 108 | Investigational Site | Elkin | North Carolina | United States | 28621 |
| 109 | Investigational Site | High Point | North Carolina | United States | 27262 |
| 110 | Investigational Site | Winston Salem | North Carolina | United States | 27103 |
| 111 | Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 112 | Investigational Site | Columbus | Ohio | United States | 43213 |
| 113 | Investigational Site | Dayton | Ohio | United States | 45406 |
| 114 | Investigational Site | Moraine | Ohio | United States | 45439 |
| 115 | Investigational Site | Toledo | Ohio | United States | 43614 |
| 116 | Investigational Site | Oklahoma City | Oklahoma | United States | 73103 |
| 117 | Investigational Site | Oklahoma City | Oklahoma | United States | 73109 |
| 118 | Investigational Site | Oklahoma City | Oklahoma | United States | 73119 |
| 119 | Investigational Site | Eugene | Oregon | United States | 97404 |
| 120 | Investigational Site | Jenkintown | Pennsylvania | United States | 19046 |
| 121 | Investigational Site | Levittown | Pennsylvania | United States | 19056 |
| 122 | Investigational Site | Mechanicsburg | Pennsylvania | United States | 17055 |
| 123 | Investigational Site | Pittsburgh | Pennsylvania | United States | 15215 |
| 124 | Investigational Site | Red Lion | Pennsylvania | United States | 17356 |
| 125 | Investigational Site | State College | Pennsylvania | United States | 16801 |
| 126 | Investigational Site | Warwick | Rhode Island | United States | 02886 |
| 127 | Investigational Site | Charleston | South Carolina | United States | 29406 |
| 128 | Investigational Site | Myrtle Beach | South Carolina | United States | 29588 |
| 129 | Investigational Site | Rapid City | South Dakota | United States | 57702 |
| 130 | Investigational Site | Jackson | Tennessee | United States | 38305 |
| 131 | Investigational Site | Allen | Texas | United States | 75013 |
| 132 | Investigational Site | Austin | Texas | United States | 78731 |
| 133 | Investigational Site | Dallas | Texas | United States | 75203 |
| 134 | Investigational Site | Dallas | Texas | United States | 75218 |
| 135 | Investigational Site | Dallas | Texas | United States | 75231 |
| 136 | Investigational Site | Dallas | Texas | United States | 75251 |
| 137 | Investigational Site | Houston | Texas | United States | 77062 |
| 138 | Investigational Site | Houston | Texas | United States | 77065 |
| 139 | Investigational Site | Houston | Texas | United States | 77074 |
| 140 | Investigational Site | Houston | Texas | United States | 77098 |
| 141 | Investigational Site | McKinney | Texas | United States | 75070 |
| 142 | Investigational Site | North Richland Hills | Texas | United States | 76180 |
| 143 | Investigational Site | Tomball | Texas | United States | 77375 |
| 144 | Investigational Site | Orem | Utah | United States | 84058 |
| 145 | Investigational Site | Salt Lake City | Utah | United States | 84102 |
| 146 | Investigational Site | Salt Lake City | Utah | United States | 84124 |
| 147 | Investigational Site | Danville | Virginia | United States | 24541 |
| 148 | Investigational Site | Midlothian | Virginia | United States | 23114 |
| 149 | Investigational Site | Richmond | Virginia | United States | 23220 |
| 150 | Investigational Site | Bothell | Washington | United States | 98011 |
Sponsors and Collaborators
- Purdue Pharma LP
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01427283
Other Study ID Numbers:
- ONU3705
- 2011-005061-20
First Posted:
Sep 1, 2011
Last Update Posted:
Feb 12, 2015
Last Verified:
Feb 1, 2015
Keywords provided by Purdue Pharma LP
Additional relevant MeSH terms: