Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Sponsor
Cubist Pharmaceuticals LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00241722
Collaborator
GlaxoSmithKline (Industry)
805
227
2
18
3.5
0.2
Study Details
Study Description
Brief Summary
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
805 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Actual Study Start Date
:
Aug 1, 2005
Actual Primary Completion Date
:
Feb 1, 2007
Actual Study Completion Date
:
Feb 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alvimopan 0.5 mg Twice Daily (BID) 0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months. |
Drug: Alvimopan
|
| Placebo Comparator: Placebo Placebo was administered orally BID for 12 months. |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- To compare alvimopan with placebo for long-term safety and tolerability [12 months]
Secondary Outcome Measures
- Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Consented to participate in this study.
-
Taking opioid therapy for persistent non-cancer pain.
-
Has bowel dysfunction mainly due to opioids.
-
Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
-
Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
Exclusion criteria:
-
Pregnant, lactating, or planning to become pregnant.
-
Not ambulatory.
-
Participated in another trial with an investigational drug in the past 30 days.
-
Taking opioids for the management of drug addiction or cancer-related pain.
-
Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
-
Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
-
Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Birmingham | Alabama | United States | 35215 |
| 2 | GSK Investigational Site | Birmingham | Alabama | United States | 35242 |
| 3 | GSK Investigational Site | Birmingham | Alabama | United States | 35244 |
| 4 | GSK Investigational Site | Huntsville | Alabama | United States | 35801 |
| 5 | GSK Investigational Site | Mobile | Alabama | United States | 36606 |
| 6 | GSK Investigational Site | Muscle Shoals | Alabama | United States | 35662 |
| 7 | GSK Investigational Site | Northport | Alabama | United States | 35476 |
| 8 | GSK Investigational Site | Glendale | Arizona | United States | 85306 |
| 9 | GSK Investigational Site | Phoenix | Arizona | United States | 85023 |
| 10 | GSK Investigational Site | Phoenix | Arizona | United States | 85029 |
| 11 | GSK Investigational Site | Phoenix | Arizona | United States | 85032 |
| 12 | GSK Investigational Site | Scottsdale | Arizona | United States | 85251 |
| 13 | GSK Investigational Site | Scottsdale | Arizona | United States | 85258 |
| 14 | GSK Investigational Site | Sun City | Arizona | United States | 85351 |
| 15 | GSK Investigational Site | Tempe | Arizona | United States | 85282 |
| 16 | GSK Investigational Site | Tucson | Arizona | United States | 85712 |
| 17 | GSK Investigational Site | Tucson | Arizona | United States | 85741 |
| 18 | GSK Investigational Site | Hot Springs | Arkansas | United States | 71913 |
| 19 | GSK Investigational Site | Little Rock | Arkansas | United States | 72223 |
| 20 | GSK Investigational Site | Anaheim | California | United States | 92801 |
| 21 | GSK Investigational Site | Anaheim | California | United States | 92805 |
| 22 | GSK Investigational Site | Bakersfield | California | United States | 93311 |
| 23 | GSK Investigational Site | Beverly Hills | California | United States | 90211 |
| 24 | GSK Investigational Site | Buena Park | California | United States | 90620 |
| 25 | GSK Investigational Site | Burbank | California | United States | 91505 |
| 26 | GSK Investigational Site | Los Gatos | California | United States | 95032 |
| 27 | GSK Investigational Site | Orange | California | United States | 92868 |
| 28 | GSK Investigational Site | Palm Springs | California | United States | 92262 |
| 29 | GSK Investigational Site | Pismo Beach | California | United States | 93449 |
| 30 | GSK Investigational Site | San Diego | California | United States | 92108 |
| 31 | GSK Investigational Site | San Diego | California | United States | 92120 |
| 32 | GSK Investigational Site | San Diego | California | United States | 92121 |
| 33 | GSK Investigational Site | Torrance | California | United States | 90503 |
| 34 | GSK Investigational Site | Vista | California | United States | 92083 |
| 35 | GSK Investigational Site | Stratford | Connecticut | United States | 6497 |
| 36 | GSK Investigational Site | Trumbull | Connecticut | United States | 06611 |
| 37 | GSK Investigational Site | Brandon | Florida | United States | 33511 |
| 38 | GSK Investigational Site | Chiefland | Florida | United States | 32626 |
| 39 | GSK Investigational Site | Clearwater | Florida | United States | 33756 |
| 40 | GSK Investigational Site | Clearwater | Florida | United States | 33765 |
| 41 | GSK Investigational Site | Deerfield Beach | Florida | United States | 33441 |
| 42 | GSK Investigational Site | DeLand | Florida | United States | 32720 |
| 43 | GSK Investigational Site | Fort Myers | Florida | United States | 33907 |
| 44 | GSK Investigational Site | Gainesville | Florida | United States | 32607 |
| 45 | GSK Investigational Site | Holly Hill | Florida | United States | 32117 |
| 46 | GSK Investigational Site | Hollywood | Florida | United States | 33021 |
| 47 | GSK Investigational Site | Jupiter | Florida | United States | 33458 |
| 48 | GSK Investigational Site | Miami | Florida | United States | 33169 |
| 49 | GSK Investigational Site | Ocala | Florida | United States | 32607 |
| 50 | GSK Investigational Site | Ocala | Florida | United States | 34471 |
| 51 | GSK Investigational Site | Orlando | Florida | United States | 32804 |
| 52 | GSK Investigational Site | Ormond Beach | Florida | United States | 32174 |
| 53 | GSK Investigational Site | Saint Cloud | Florida | United States | 34769 |
| 54 | GSK Investigational Site | West Palm Beach | Florida | United States | 33409 |
| 55 | GSK Investigational Site | Dawsonville | Georgia | United States | 30534 |
| 56 | GSK Investigational Site | Marietta | Georgia | United States | 30066 |
| 57 | GSK Investigational Site | Stockbridge | Georgia | United States | 30281 |
| 58 | GSK Investigational Site | Suwanee | Georgia | United States | 30024 |
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| 60 | GSK Investigational Site | Meridian | Idaho | United States | 83642 |
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| 83 | GSK Investigational Site | Manchester | Missouri | United States | 63021 |
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| 86 | GSK Investigational Site | Missoula | Montana | United States | 59804 |
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| 88 | GSK Investigational Site | Henderson | Nevada | United States | 89015 |
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| 95 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87102 |
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| 97 | GSK Investigational Site | Asheville | North Carolina | United States | 28801 |
| 98 | GSK Investigational Site | Charlotte | North Carolina | United States | 28204 |
| 99 | GSK Investigational Site | Concord | North Carolina | United States | 28025 |
| 100 | GSK Investigational Site | Greensboro | North Carolina | United States | 27401 |
| 101 | GSK Investigational Site | Greensboro | North Carolina | United States | 27403 |
| 102 | GSK Investigational Site | Hickory | North Carolina | United States | 28601 |
| 103 | GSK Investigational Site | Raleigh | North Carolina | United States | 27607 |
| 104 | GSK Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 105 | GSK Investigational Site | Centerville | Ohio | United States | 45450 |
| 106 | GSK Investigational Site | Cincinnati | Ohio | United States | 45219 |
| 107 | GSK Investigational Site | Cincinnati | Ohio | United States | 45224 |
| 108 | GSK Investigational Site | Columbus | Ohio | United States | 43215 |
| 109 | GSK Investigational Site | Dayton | Ohio | United States | 45408 |
| 110 | GSK Investigational Site | Dayton | Ohio | United States | 45439 |
| 111 | GSK Investigational Site | Dayton | Ohio | United States | 46432 |
| 112 | GSK Investigational Site | Clinton | Oklahoma | United States | 73601 |
| 113 | GSK Investigational Site | Oklahoma City | Oklahoma | United States | 73112 |
| 114 | GSK Investigational Site | Medford | Oregon | United States | 97504 |
| 115 | GSK Investigational Site | Oregon City | Oregon | United States | 97045 |
| 116 | GSK Investigational Site | Portland | Oregon | United States | 97210 |
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| 118 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15243 |
| 119 | GSK Investigational Site | Reading | Pennsylvania | United States | 19611 |
| 120 | GSK Investigational Site | Woonsocket | Rhode Island | United States | 02895 |
| 121 | GSK Investigational Site | Chattanooga | Tennessee | United States | 37403 |
| 122 | GSK Investigational Site | Clarksville | Tennessee | United States | 37043 |
| 123 | GSK Investigational Site | Kingsport | Tennessee | United States | 37660 |
| 124 | GSK Investigational Site | Arlington | Texas | United States | 76017 |
| 125 | GSK Investigational Site | Brownwood | Texas | United States | 76801 |
| 126 | GSK Investigational Site | Dallas | Texas | United States | 75218 |
| 127 | GSK Investigational Site | Grand Prairie | Texas | United States | 75052 |
| 128 | GSK Investigational Site | Houston | Texas | United States | 77074 |
| 129 | GSK Investigational Site | Houston | Texas | United States | 77090 |
| 130 | GSK Investigational Site | Lake Jackson | Texas | United States | 77566 |
| 131 | GSK Investigational Site | Lancaster | Texas | United States | 75146 |
| 132 | GSK Investigational Site | Richardson | Texas | United States | 75080 |
| 133 | GSK Investigational Site | San Antonio | Texas | United States | 78238 |
| 134 | GSK Investigational Site | Salt Lake City | Utah | United States | 84106 |
| 135 | GSK Investigational Site | Salt Lake City | Utah | United States | 84120 |
| 136 | GSK Investigational Site | Norfolk | Virginia | United States | 23502 |
| 137 | GSK Investigational Site | Richmond | Virginia | United States | 23294 |
| 138 | GSK Investigational Site | Virginia Beach | Virginia | United States | 23452 |
| 139 | GSK Investigational Site | Bellingham | Washington | United States | 98226 |
| 140 | GSK Investigational Site | Edmonds | Washington | United States | 98026 |
| 141 | GSK Investigational Site | Spokane | Washington | United States | 99204 |
| 142 | GSK Investigational Site | Tacoma | Washington | United States | 98405 |
| 143 | GSK Investigational Site | Charleston | West Virginia | United States | 25304 |
| 144 | GSK Investigational Site | Broadmeadow | New South Wales | Australia | 2292 |
| 145 | GSK Investigational Site | St Leonards | New South Wales | Australia | 2065 |
| 146 | GSK Investigational Site | Carina Heights | Queensland | Australia | 4152 |
| 147 | GSK Investigational Site | Kippa Ring | Queensland | Australia | 4021 |
| 148 | GSK Investigational Site | Bedford Park | South Australia | Australia | 5042 |
| 149 | GSK Investigational Site | Port Lincoln | South Australia | Australia | 5606 |
| 150 | GSK Investigational Site | Toorak Gardens | South Australia | Australia | 5065 |
| 151 | GSK Investigational Site | Box Hill | Victoria | Australia | 3128 |
| 152 | GSK Investigational Site | Carlton | Victoria | Australia | 3053 |
| 153 | GSK Investigational Site | Fremantle | Western Australia | Australia | 6160 |
| 154 | GSK Investigational Site | Vienna | Austria | A-1100 | |
| 155 | GSK Investigational Site | Vienna | Austria | A-1130 | |
| 156 | GSK Investigational Site | Calgary | Alberta | Canada | T3C 3P1 |
| 157 | GSK Investigational Site | Edmonton | Alberta | Canada | T5A 4L8 |
| 158 | GSK Investigational Site | Coquitlam | British Columbia | Canada | V3K 3P4 |
| 159 | GSK Investigational Site | Kelowna | British Columbia | Canada | V1Y 2H4 |
| 160 | GSK Investigational Site | Langley | British Columbia | Canada | V3A 4H9 |
| 161 | GSK Investigational Site | Winnipeg | Manitoba | Canada | R3A 1R9 |
| 162 | GSK Investigational Site | Moncton | New Brunswick | Canada | E1G 1A7 |
| 163 | GSK Investigational Site | Saint John's | Newfoundland and Labrador | Canada | A1E 2C2 |
| 164 | GSK Investigational Site | Halifax | Nova Scotia | Canada | B3K 5R3 |
| 165 | GSK Investigational Site | Brampton | Ontario | Canada | L6T 3J1 |
| 166 | GSK Investigational Site | Hamilton | Ontario | Canada | L8L 5G8 |
| 167 | GSK Investigational Site | Kitchener | Ontario | Canada | N2M 5N6 |
| 168 | GSK Investigational Site | Mississauga | Ontario | Canada | L4T 4J2 |
| 169 | GSK Investigational Site | North Bay | Ontario | Canada | P1B 2H3 |
| 170 | GSK Investigational Site | North York | Ontario | Canada | M2M 4E7 |
| 171 | GSK Investigational Site | Sudbury | Ontario | Canada | P3E 1H5 |
| 172 | GSK Investigational Site | Toronto | Ontario | Canada | M3H 5S4 |
| 173 | GSK Investigational Site | Toronto | Ontario | Canada | M3J 1N2 |
| 174 | GSK Investigational Site | Toronto | Ontario | Canada | M3N 2V7 |
| 175 | GSK Investigational Site | Toronto | Ontario | Canada | M9W 4L6 |
| 176 | GSK Investigational Site | Charlottetown | Prince Edward Island | Canada | C1A 8T5 |
| 177 | GSK Investigational Site | Bonaventure | Quebec | Canada | G0C 1E0 |
| 178 | GSK Investigational Site | Chandler | Quebec | Canada | G0C 1K0 |
| 179 | GSK Investigational Site | Drummondville | Quebec | Canada | J2B 1H8 |
| 180 | GSK Investigational Site | Mirabel | Quebec | Canada | J7J 2K8 |
| 181 | GSK Investigational Site | Montreal | Quebec | Canada | H3M 3A9 |
| 182 | GSK Investigational Site | Saint Romuald | Quebec | Canada | G6W 5M6 |
| 183 | GSK Investigational Site | Sherbrooke | Quebec | Canada | J1H 1Z1 |
| 184 | GSK Investigational Site | Trois-Rivieres | Quebec | Canada | G8Z 1Y2 |
| 185 | GSK Investigational Site | Ishoj | Denmark | 2635 | |
| 186 | GSK Investigational Site | Helsinki | Finland | 00029 | |
| 187 | GSK Investigational Site | Kowloon | Hong Kong | ||
| 188 | GSK Investigational Site | Kwun Tong | Hong Kong | ||
| 189 | GSK Investigational Site | Pokfulam | Hong Kong | ||
| 190 | GSK Investigational Site | Shatin | Hong Kong | ||
| 191 | GSK Investigational Site | Budapest | Hungary | 1083 | |
| 192 | GSK Investigational Site | Cork | Ireland | ||
| 193 | GSK Investigational Site | Roosendaal | Netherlands | 4708 AE | |
| 194 | GSK Investigational Site | Utrecht | Netherlands | 3584 CX | |
| 195 | GSK Investigational Site | Christchurch | New Zealand | ||
| 196 | GSK Investigational Site | Hamilton | New Zealand | 2001 | |
| 197 | GSK Investigational Site | Tauranga | New Zealand | 3001 | |
| 198 | GSK Investigational Site | Gdansk | Poland | 80-952 | |
| 199 | GSK Investigational Site | Krakow | Poland | 31-531 | |
| 200 | GSK Investigational Site | Wroclaw | Poland | 50-368 | |
| 201 | GSK Investigational Site | Alcorcon | Spain | 28922 | |
| 202 | GSK Investigational Site | Barcelona | Spain | 08003 | |
| 203 | GSK Investigational Site | El Ferrol | Spain | ||
| 204 | GSK Investigational Site | Granada | Spain | 18012 | |
| 205 | GSK Investigational Site | Madrid | Spain | 28006 | |
| 206 | GSK Investigational Site | Madrid | Spain | 28034 | |
| 207 | GSK Investigational Site | Santander | Spain | 39008 | |
| 208 | GSK Investigational Site | Valencia | Spain | 46014 | |
| 209 | GSK Investigational Site | Jönköping | Sweden | SE-551 85 | |
| 210 | GSK Investigational Site | Karlstad | Sweden | SE-651 85 | |
| 211 | GSK Investigational Site | Linköping | Sweden | SE-581 85 | |
| 212 | GSK Investigational Site | Stockholm | Sweden | SE-141 86 | |
| 213 | GSK Investigational Site | Bern | Switzerland | 3011 | |
| 214 | GSK Investigational Site | Tainan | Taiwan | 704 | |
| 215 | GSK Investigational Site | Taipei | Taiwan | 100 | |
| 216 | GSK Investigational Site | Taipei | Taiwan | 114 | |
| 217 | GSK Investigational Site | Reading | Berkshire | United Kingdom | RG7 3SQ |
| 218 | GSK Investigational Site | Slough | Berkshire | United Kingdom | SL2 1HD |
| 219 | GSK Investigational Site | Cardiff | Glamorgan | United Kingdom | CF14 9BB |
| 220 | GSK Investigational Site | Glasgow | Lanarkshire | United Kingdom | G3 8YJ |
| 221 | GSK Investigational Site | Glasgow | Lanarkshire | United Kingdom | G69 7AD |
| 222 | GSK Investigational Site | Sunbury-on-Thames | Middlesex | United Kingdom | TW16 6RH |
| 223 | GSK Investigational Site | Coventry | Warwickshire | United Kingdom | CV6 4DD |
| 224 | GSK Investigational Site | Bexhill-on-Sea, East Sussex | United Kingdom | TN39 4SP | |
| 225 | GSK Investigational Site | Leeds | United Kingdom | LS14 6UH | |
| 226 | GSK Investigational Site | London | United Kingdom | EC1A 7BE | |
| 227 | GSK Investigational Site | Yaxley, Peterborough | United Kingdom | PE7 3JL |
Sponsors and Collaborators
- Cubist Pharmaceuticals LLC
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, MD, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00241722
Other Study ID Numbers:
- 3753-013
- SB-767905/014
First Posted:
Oct 19, 2005
Last Update Posted:
Aug 30, 2017
Last Verified:
Aug 1, 2017
Keywords provided by Cubist Pharmaceuticals LLC
Additional relevant MeSH terms: