Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain
Sponsor
Purdue Pharma LP (Industry)
Overall Status
Completed
CT.gov ID
NCT01427270
Collaborator
(none)
455
194
3
38
2.3
0.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
455 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 Uncontrolled 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 the past 2 years, with the 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 | 35242 |
| 3 | Investigational Site | Gulf Shores | Alabama | United States | 36542 |
| 4 | Investigational Site | Homewood | Alabama | United States | 35209 |
| 5 | Investigational Site | Huntsville | Alabama | United States | 35801 |
| 6 | Investigational Site | Mobile | Alabama | United States | 36608 |
| 7 | Investigational Site | Goodyear | Arizona | United States | 85395-2511 |
| 8 | Investigational Site | Goodyear | Arizona | United States | 85395 |
| 9 | Investigational Site | Phoenix | Arizona | United States | 85018 |
| 10 | Investigational Site | Phoenix | Arizona | United States | 85027 |
| 11 | Investigational Site | Tempe | Arizona | United States | 85282 |
| 12 | Investigational Site | Tucson | Arizona | United States | 85704 |
| 13 | Investigational Site | Hot Springs | Arkansas | United States | 71901 |
| 14 | Investigational Site | Little Rock | Arkansas | United States | 72211 |
| 15 | Investigational Site | Anaheim | California | United States | 92801 |
| 16 | Investigational Site | Anaheim | California | United States | 92804 |
| 17 | Investigational Site | Anaheim | California | United States | 92805 |
| 18 | Investigational Site | Chino | California | United States | 91710 |
| 19 | Investigational Site | Fresno | California | United States | 93720 |
| 20 | Investigational Site | Fresno | California | United States | 93726 |
| 21 | Investigational Site | Glendale | California | United States | 91206 |
| 22 | Investigational Site | La Mesa | California | United States | 91942 |
| 23 | Investigational Site | Laguna Hills | California | United States | 92637 |
| 24 | Investigational Site | Long Beach | California | United States | 90806 |
| 25 | Investigational Site | Los Angeles | California | United States | 90017 |
| 26 | Investigational Site | Los Angeles | California | United States | 90025 |
| 27 | Investigational Site | Los Angeles | California | United States | 90036 |
| 28 | Investigational Site | Los Gatos | California | United States | 95032 |
| 29 | Investigational Site | National City | California | United States | 91950 |
| 30 | Investigational Site | North Hollywood | California | United States | 91606 |
| 31 | Investigational Site | Oceanside | California | United States | 92056 |
| 32 | Investigational Site | Paramount | California | United States | 90723 |
| 33 | Investigational Site | Richmond | California | United States | 94806 |
| 34 | Investigational Site | Roseville | California | United States | 95661 |
| 35 | Investigational Site | Sacramento | California | United States | 95823 |
| 36 | Investigational Site | Sacramento | California | United States | 95842 |
| 37 | Investigational Site | San Diego | California | United States | 92114 |
| 38 | Investigational Site | Santa Ana | California | United States | 92701 |
| 39 | Investigational Site | Santa Clarita | California | United States | 91350 |
| 40 | Investigational Site | Valley Village | California | United States | 91607 |
| 41 | Investigational Site | Golden | Colorado | United States | 80401 |
| 42 | Investigational Site | New Haven | Connecticut | United States | 06511 |
| 43 | Investigational Site | Waterbury | Connecticut | United States | 06708 |
| 44 | Investigational Site | Aventura | Florida | United States | 33180 |
| 45 | Investigational Site | Boynton Beach | Florida | United States | 33472 |
| 46 | Investigational Site | Bradenton | Florida | United States | 34209 |
| 47 | Investigational Site | Clearwater | Florida | United States | 33765 |
| 48 | Investigational Site | Clermont | Florida | United States | 34711 |
| 49 | Investigational Site | Coral Gables | Florida | United States | 33134 |
| 50 | Investigational Site | Daytona Beach | Florida | United States | 32117 |
| 51 | Investigational Site | Ft. Lauderdale | Florida | United States | 33316 |
| 52 | Investigational Site | Hialeah | Florida | United States | 33012 |
| 53 | Investigational Site | Hialeah | Florida | United States | 33013 |
| 54 | Investigational Site | Inverness | Florida | United States | 34452 |
| 55 | Investigational Site | Jacksonville | Florida | United States | 32216 |
| 56 | Investigational Site | Jacksonville | Florida | United States | 32257 |
| 57 | Investigational Site | Jupiter | Florida | United States | 33458 |
| 58 | Investigational Site | Miami Lakes | Florida | United States | 33014 |
| 59 | Investigational Site | Miami | Florida | United States | 33125 |
| 60 | Investigational Site | Miami | Florida | United States | 33126 |
| 61 | Investigational Site | Miami | Florida | United States | 33135 |
| 62 | Investigational Site | Miami | Florida | United States | 33143 |
| 63 | Investigational Site | Miami | Florida | United States | 33185 |
| 64 | Investigational Site | Naples | Florida | United States | 34110 |
| 65 | Investigational Site | Naples | Florida | United States | 34113 |
| 66 | Investigational Site | New Port Richey | Florida | United States | 34652 |
| 67 | Investigational Site | North Miami Beach | Florida | United States | 33162 |
| 68 | Investigational Site | Orlando | Florida | United States | 32806 |
| 69 | Investigational Site | Oviedo | Florida | United States | 32765 |
| 70 | Investigational Site | Pinellas Park | Florida | United States | 33781 |
| 71 | Investigational Site | Pinellas Park | Florida | United States | 33782 |
| 72 | Investigational Site | Plantation | Florida | United States | 33317 |
| 73 | Investigational Site | Port Orange | Florida | United States | 32129 |
| 74 | Investigational Site | Sanford | Florida | United States | 32771 |
| 75 | Investigational Site | South Miami | Florida | United States | 33143 |
| 76 | Investigational Site | Tamarac | Florida | United States | 33321 |
| 77 | Investigational Site | Tampa | Florida | United States | 33607 |
| 78 | Investigational Site | Tampa | Florida | United States | 33613 |
| 79 | Investigational Site | Wellington | Florida | United States | 33414 |
| 80 | Investigational Site | Austell | Georgia | United States | 30106 |
| 81 | Investigational Site | Blue Ridge | Georgia | United States | 30513 |
| 82 | Investigational Site | Canton | Georgia | United States | 30114 |
| 83 | Investigational Site | Columbus | Georgia | United States | 31904 |
| 84 | Investigational Site | Johns Creek | Georgia | United States | 30097 |
| 85 | Investigational Site | Marietta | Georgia | United States | 30060 |
| 86 | Investigational Site | Perry | Georgia | United States | 31069 |
| 87 | Investigational Site | Savannah | Georgia | United States | 31405 |
| 88 | Investigational Site | Boise | Idaho | United States | 83702 |
| 89 | Investigational Site | Meridian | Idaho | United States | 83642 |
| 90 | Investigational Site | Bloomington | Illinois | United States | 61701 |
| 91 | Investigational Site | Chicago | Illinois | United States | 60657 |
| 92 | Investigational Site | Evansville | Indiana | United States | 47714 |
| 93 | Investigational Site | Kansas City | Kansas | United States | 66160 |
| 94 | Investigational Site | Wichita | Kansas | United States | 67203 |
| 95 | Investigational Site | Lexington | Kentucky | United States | 40504 |
| 96 | Investigational Site | Madisonville | Kentucky | United States | 42431 |
| 97 | Investigational Site | Baton Rouge | Louisiana | United States | 70809 |
| 98 | Investigational Site | Covington | Louisiana | United States | 70435 |
| 99 | Investigational Site | Marrero | Louisiana | United States | 70072 |
| 100 | Investigational Site | Metairie | Louisiana | United States | 70006 |
| 101 | Investigational Site | Hollywood | Maryland | United States | 20636 |
| 102 | Investigational Site | Fall River | Massachusetts | United States | 02720 |
| 103 | Investigational Site | North Attleboro | Massachusetts | United States | 02760 |
| 104 | Investigational Site | Bay City | Michigan | United States | 48706 |
| 105 | Investigational Site | Pinconning | Michigan | United States | 48650 |
| 106 | Investigational Site | Rochester | Michigan | United States | 48307 |
| 107 | Investigational Site | Troy | Michigan | United States | 48085 |
| 108 | Investigational Site | Hazelwood | Missouri | United States | 63042 |
| 109 | Investigational Site | St. Louis | Missouri | United States | 63128 |
| 110 | Investigational Site | St. Louis | Missouri | United States | 63141 |
| 111 | Investigational Site | Las Vegas | Nevada | United States | 89119 |
| 112 | Investigational Site | Stratford | New Jersey | United States | 08084 |
| 113 | Investigational Site | Toms River | New Jersey | United States | 08755 |
| 114 | Investigational Site | Voorhees | New Jersey | United States | 08034 |
| 115 | Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 116 | Investigational Site | Cedarhurst | New York | United States | 11516 |
| 117 | Investigational Site | Great Neck | New York | United States | 11023 |
| 118 | Investigational Site | New Windsor | New York | United States | 12553 |
| 119 | Investigational Site | New York | New York | United States | 10022 |
| 120 | Investigational Site | North Massapequa | New York | United States | 11758 |
| 121 | Investigational Site | Williamsville | New York | United States | 14221 |
| 122 | Investigational Site | Elkin | North Carolina | United States | 28621 |
| 123 | Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 124 | Investigational Site | Beavercreek | Ohio | United States | 45432 |
| 125 | Investigational Site | Cincinnati | Ohio | United States | 45242 |
| 126 | Investigational Site | Cleveland | Ohio | United States | 44122 |
| 127 | Investigational Site | Columbus | Ohio | United States | 43210 |
| 128 | Investigational Site | Columbus | Ohio | United States | 43214 |
| 129 | Investigational Site | Franklin | Ohio | United States | 45005 |
| 130 | Investigational Site | Groveport | Ohio | United States | 43125 |
| 131 | Investigational Site | Toledo | Ohio | United States | 43623 |
| 132 | Investigational Site | Oklahoma City | Oklahoma | United States | 73119 |
| 133 | Investigational Site | Altoona | Pennsylvania | United States | 16602 |
| 134 | Investigational Site | Jenkintown | Pennsylvania | United States | 19046 |
| 135 | Investigational Site | Johnstown | Pennsylvania | United States | 15904 |
| 136 | Investigational Site | Philadelphia | Pennsylvania | United States | 19152 |
| 137 | Investigational Site | Phoenixville | Pennsylvania | United States | 19460 |
| 138 | Investigational Site | Tipton | Pennsylvania | United States | 16684 |
| 139 | Investigational Site | Warwick | Rhode Island | United States | 02886 |
| 140 | Investigational Site | Myrtle Beach | South Carolina | United States | 29588 |
| 141 | Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 142 | Investigational Site | Franklin | Tennessee | United States | 37067 |
| 143 | Investigational Site | New Tazewell | Tennessee | United States | 37825 |
| 144 | Investigational Site | Arlington | Texas | United States | 76011 |
| 145 | Investigational Site | Athens | Texas | United States | 75751 |
| 146 | Investigational Site | Austin | Texas | United States | 78756 |
| 147 | Investigational Site | Dallas | Texas | United States | 75231 |
| 148 | Investigational Site | Dallas | Texas | United States | 75251 |
| 149 | Investigational Site | Houston | Texas | United States | 77005 |
| 150 | Investigational Site | Houston | Texas | United States | 77024 |
| 151 | Investigational Site | Houston | Texas | United States | 77025 |
| 152 | Investigational Site | Houston | Texas | United States | 77030 |
| 153 | Investigational Site | Houston | Texas | United States | 77057 |
| 154 | Investigational Site | Houston | Texas | United States | 77065 |
| 155 | Investigational Site | Houston | Texas | United States | 77074 |
| 156 | Investigational Site | Houston | Texas | United States | 77098 |
| 157 | Investigational Site | Humble | Texas | United States | 77338 |
| 158 | Investigational Site | North Richland Hills | Texas | United States | 76180 |
| 159 | Investigational Site | Plano | Texas | United States | 75075 |
| 160 | Investigational Site | San Antonio | Texas | United States | 78229 |
| 161 | Investigational Site | San Antonio | Texas | United States | 78238 |
| 162 | Investigational Site | Sugar Land | Texas | United States | 77478 |
| 163 | Investigational Site | Tomball | Texas | United States | 77375 |
| 164 | Investigational Site | Clinton | Utah | United States | 84015 |
| 165 | Investigational Site | Salt Lake City | Utah | United States | 84102 |
| 166 | Investigational Site | Salt Lake City | Utah | United States | 84107 |
| 167 | Investigational Site | West Jordan | Utah | United States | 84088 |
| 168 | Investigational Site | Richmond | Virginia | United States | 23220 |
| 169 | Investigational Site | Richmond | Virginia | United States | 23235 |
| 170 | Investigational Site | Virginia Beach | Virginia | United States | 23454 |
| 171 | Investigational Site | Brno | Czech Republic | 656 91 | |
| 172 | Investigational Site | Hradec Kralove | Czech Republic | 500 03 | |
| 173 | Investigational Site | Most | Czech Republic | 434 64 | |
| 174 | Investigational Site | Olomouc | Czech Republic | 775 20 | |
| 175 | Investigational Site | Praha 10 | Czech Republic | 100 00 | |
| 176 | Investigational Site | Praha 4 - Krc | Czech Republic | 140 59 | |
| 177 | Investigational Site | Praha 6 | Czech Republic | 160 00 | |
| 178 | Investigational Site | Rychnov nad Kneznou | Czech Republic | 516 01 | |
| 179 | Investigational Site | Sternberk | Czech Republic | 785 01 | |
| 180 | Investigational Site | Vysoke Myto | Czech Republic | 566 23 | |
| 181 | Investigational Site | Zlin | Czech Republic | 760 01 | |
| 182 | Investigational Site | Znojmo | Czech Republic | 669 02 | |
| 183 | Investigational Site | Catania | Italy | 95123 | |
| 184 | Investigational Site | Bielsko-Biala | Poland | 43-300 | |
| 185 | Investigational Site | Bydgoszcz | Poland | 85-079 | |
| 186 | Investigational Site | Bydgoszcz | Poland | 85-796 | |
| 187 | Investigational Site | Gdansk | Poland | 80-286 | |
| 188 | Investigational Site | Gdansk | Poland | 80-546 | |
| 189 | Investigational Site | Gdynia | Poland | 81-366 | |
| 190 | Investigational Site | Katowice | Poland | 40-084 | |
| 191 | Investigational Site | Katowice | Poland | 40-683 | |
| 192 | Investigational Site | Lublin | Poland | 20-582 | |
| 193 | Investigational Site | Lublin | Poland | 20-718 | |
| 194 | Investigational Site | Torun | Poland | 87-100 |
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:
NCT01427270
Other Study ID Numbers:
- ONU3704
- 2011-005060-26
First Posted:
Sep 1, 2011
Last Update Posted:
Nov 7, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Purdue Pharma LP
Additional relevant MeSH terms: