Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Public ClinicalTrials.gov record NCT00259922. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
Study identification
- NCT ID
- NCT00259922
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Industry
- Enrollment
- 485 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2005 (Type not available)
- Primary completion
- Jun 2006 (Actual)
- Completion
- Not listed
- Last update posted
- Sep 2, 2015
Started 2005
United States locations
- U.S. sites
- 119
- U.S. states
- 36
- U.S. cities
- 107
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35215 | — |
| GSK Investigational Site | Birmingham | Alabama | 35216 | — |
| GSK Investigational Site | Huntsville | Alabama | 35801 | — |
| GSK Investigational Site | Mobile | Alabama | 36606 | — |
| GSK Investigational Site | Northport | Alabama | 35476 | — |
| GSK Investigational Site | Mesa | Arizona | 85205 | — |
| GSK Investigational Site | Phoenix | Arizona | 85029 | — |
| GSK Investigational Site | Scottsdale | Arizona | 85251 | — |
| GSK Investigational Site | Scottsdale | Arizona | 85258 | — |
| GSK Investigational Site | Tempe | Arizona | 85282 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | Tucson | Arizona | 85724 | — |
| GSK Investigational Site | Bakersfield | California | 93311 | — |
| GSK Investigational Site | Beverly Hills | California | 90211 | — |
| GSK Investigational Site | Long Beach | California | 90813 | — |
| GSK Investigational Site | Los Angeles | California | 90048 | — |
| GSK Investigational Site | Los Gatos | California | 95032 | — |
| GSK Investigational Site | Northridge | California | 91325 | — |
| GSK Investigational Site | Orange | California | 92868 | — |
| GSK Investigational Site | Palm Springs | California | 92262 | — |
| GSK Investigational Site | Pasadena | California | 91105 | — |
| GSK Investigational Site | Sacramento | California | 95816 | — |
| GSK Investigational Site | San Diego | California | 92108 | — |
| GSK Investigational Site | San Rafael | California | 94901 | — |
| GSK Investigational Site | Santa Ana | California | 92704 | — |
| GSK Investigational Site | Stamford | Connecticut | 06905 | — |
| GSK Investigational Site | Waterbury | Connecticut | 06708 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20003 | — |
| GSK Investigational Site | Chiefland | Florida | 32626 | — |
| GSK Investigational Site | Clearwater | Florida | 33761 | — |
| GSK Investigational Site | Deerfield Beach | Florida | 33441 | — |
| GSK Investigational Site | Destin | Florida | 32541 | — |
| GSK Investigational Site | Fort Myers | Florida | 33916 | — |
| GSK Investigational Site | Hollywood | Florida | 33021 | — |
| GSK Investigational Site | Hollywood | Florida | 33023 | — |
| GSK Investigational Site | Largo | Florida | 33770 | — |
| GSK Investigational Site | Margate | Florida | 33063 | — |
| GSK Investigational Site | Miami | Florida | 33138 | — |
| GSK Investigational Site | Miami | Florida | 33155 | — |
| GSK Investigational Site | Miami | Florida | 33169 | — |
| GSK Investigational Site | Ocala | Florida | 34471 | — |
| GSK Investigational Site | Ormond Beach | Florida | 32174 | — |
| GSK Investigational Site | Saint Cloud | Florida | 34769 | — |
| GSK Investigational Site | Tampa | Florida | 33614 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | — |
| GSK Investigational Site | Winterhaven | Florida | 33880 | — |
| GSK Investigational Site | Atlanta | Georgia | 30338 | — |
| GSK Investigational Site | Atlanta | Georgia | 30342 | — |
| GSK Investigational Site | Cumming | Georgia | 30040 | — |
| GSK Investigational Site | Marietta | Georgia | 30066 | — |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | — |
| GSK Investigational Site | Meridian | Idaho | 83642 | — |
| GSK Investigational Site | Chicago | Illinois | 60610 | — |
| GSK Investigational Site | Libertyville | Illinois | 60048 | — |
| GSK Investigational Site | Oak Forest | Illinois | 60452 | — |
| GSK Investigational Site | Oakbrook Terrace | Illinois | 60181 | — |
| GSK Investigational Site | Evansville | Indiana | 47714 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46250 | — |
| GSK Investigational Site | Lexington | Kentucky | 40536 | — |
| GSK Investigational Site | Louisville | Kentucky | 40205 | — |
| GSK Investigational Site | Sunset | Louisiana | 70584 | — |
| GSK Investigational Site | Pasadena | Maryland | 21122 | — |
| GSK Investigational Site | Rockville | Maryland | 20852 | — |
| GSK Investigational Site | Boston | Massachusetts | 02115 | — |
| GSK Investigational Site | Brockton | Massachusetts | 02301 | — |
| GSK Investigational Site | Wellesley Hills | Massachusetts | 02481 | — |
| GSK Investigational Site | Portage | Michigan | 49024 | — |
| GSK Investigational Site | Waterford | Michigan | 48327 | — |
| GSK Investigational Site | Olive Branch | Mississippi | 38654 | — |
| GSK Investigational Site | Independence | Missouri | 64055 | — |
| GSK Investigational Site | St Louis | Missouri | 63108 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Missoula | Montana | 59804 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89102 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89103 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89146 | — |
| GSK Investigational Site | Dover | New Hampshire | 03820 | — |
| GSK Investigational Site | Blackwood | New Jersey | 08012 | — |
| GSK Investigational Site | Egg Harbor | New Jersey | 08234 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87102 | — |
| GSK Investigational Site | Mineola | New York | 11501 | — |
| GSK Investigational Site | New York | New York | 10022 | — |
| GSK Investigational Site | Rochester | New York | 14627 | — |
| GSK Investigational Site | Asheville | North Carolina | 28801 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27403 | — |
| GSK Investigational Site | Hickory | North Carolina | 28601 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Centerville | Ohio | 45450 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45236 | — |
| GSK Investigational Site | Dayton | Ohio | 46432 | — |
| GSK Investigational Site | Perrysburg | Ohio | 43551 | — |
| GSK Investigational Site | Eugene | Oregon | 97401 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Salem | Oregon | 97301 | — |
| GSK Investigational Site | Levittown | Pennsylvania | 19056 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15243 | — |
| GSK Investigational Site | Reading | Pennsylvania | 19611 | — |
| GSK Investigational Site | Cranston | Rhode Island | 02920 | — |
| GSK Investigational Site | Greer | South Carolina | 29651 | — |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | — |
| GSK Investigational Site | New Tazewell | Tennessee | 37824-1409 | — |
| GSK Investigational Site | Austin | Texas | 78756 | — |
| GSK Investigational Site | Corpus Christi | Texas | 78404 | — |
| GSK Investigational Site | Galveston | Texas | 77555-0188 | — |
| GSK Investigational Site | Houston | Texas | 77070 | — |
| GSK Investigational Site | Richardson | Texas | 75080 | — |
| GSK Investigational Site | San Antonio | Texas | 78217 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Richmond | Virginia | 23294 | — |
| GSK Investigational Site | Spokane | Washington | 99207 | — |
| GSK Investigational Site | Tacoma | Washington | 98405 | — |
| GSK Investigational Site | Yakima | Washington | 98902 | — |
| GSK Investigational Site | Charleston | West Virginia | 25304 | — |
| GSK Investigational Site | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 68 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00259922, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2015 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00259922 live on ClinicalTrials.gov.