ClinicalTrials.gov record
Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
ClinicalTrials.gov ID: NCT00256932
Public ClinicalTrials.gov record NCT00256932. 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 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
- NCT00256932
- 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
- 518 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
- Not listed
- Completion
- May 2006 (Actual)
- Last update posted
- Sep 2, 2015
2005 – 2006
United States locations
- U.S. sites
- 137
- U.S. states
- 32
- U.S. cities
- 117
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35243 | — |
| GSK Investigational Site | Birmingham | Alabama | 35244 | — |
| GSK Investigational Site | Calera | Alabama | 35040 | — |
| GSK Investigational Site | Muscle Shoals | Alabama | 35662 | — |
| GSK Investigational Site | Tallassee | Alabama | 36078 | — |
| GSK Investigational Site | Glendale | Arizona | 85306 | — |
| GSK Investigational Site | Phoenix | Arizona | 85023 | — |
| GSK Investigational Site | Phoenix | Arizona | 85032 | — |
| GSK Investigational Site | Sun City | Arizona | 85351 | — |
| GSK Investigational Site | Tucson | Arizona | 85711 | — |
| GSK Investigational Site | Tucson | Arizona | 85741 | — |
| GSK Investigational Site | Hot Springs | Arkansas | 71913 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72223 | — |
| GSK Investigational Site | Anaheim | California | 92801 | — |
| GSK Investigational Site | Anaheim | California | 92805 | — |
| GSK Investigational Site | Beuna Park | California | 90620 | — |
| GSK Investigational Site | Burbank | California | 91505 | — |
| GSK Investigational Site | Duarte | California | 91010 | — |
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | Huntington Beach | California | 92648 | — |
| GSK Investigational Site | Mission Viejo | California | 92691 | — |
| GSK Investigational Site | Orange | California | 92869 | — |
| GSK Investigational Site | Redlands | California | 92374 | — |
| GSK Investigational Site | San Diego | California | 92103-6204 | — |
| GSK Investigational Site | San Diego | California | 92120 | — |
| GSK Investigational Site | San Diego | California | 92121 | — |
| GSK Investigational Site | Vista | California | 92083 | — |
| GSK Investigational Site | Waterbury | Connecticut | 067708 | — |
| GSK Investigational Site | Newark | Delaware | 19713 | — |
| GSK Investigational Site | Brandon | Florida | 33511 | — |
| GSK Investigational Site | Brooksville | Florida | 34613 | — |
| GSK Investigational Site | DeLand | Florida | 32720 | — |
| GSK Investigational Site | Fort Meyers | Florida | 33907 | — |
| GSK Investigational Site | Gainsville | Florida | 32607 | — |
| GSK Investigational Site | Hollywood | Florida | 33021 | — |
| GSK Investigational Site | Jacksonville | Florida | 32256 | — |
| GSK Investigational Site | Jacksonville | Florida | 32257 | — |
| GSK Investigational Site | Jupiter | Florida | 33458 | — |
| GSK Investigational Site | Largo | Florida | 33773 | — |
| GSK Investigational Site | Melbourne | Florida | 32901 | — |
| GSK Investigational Site | Miami | Florida | 33145 | — |
| GSK Investigational Site | Miami | Florida | 33186 | — |
| GSK Investigational Site | Niceville | Florida | 32578 | — |
| GSK Investigational Site | North Miami | Florida | 33161 | — |
| GSK Investigational Site | Ocala | Florida | 32607 | — |
| GSK Investigational Site | Orlando | Florida | 32804 | — |
| GSK Investigational Site | Ormond Beach | Florida | 32174 | — |
| GSK Investigational Site | Sarasota | Florida | 34239 | — |
| GSK Investigational Site | St. Petersburg | Florida | 33703 | — |
| GSK Investigational Site | Tampa | Florida | 33603 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | — |
| GSK Investigational Site | Winter Park | Florida | 32789 | — |
| GSK Investigational Site | Atlanta | Georgia | 30308 | — |
| GSK Investigational Site | Dawsonville | Georgia | 30534 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Decatur | Georgia | 30034 | — |
| GSK Investigational Site | Marietta | Georgia | 30066 | — |
| GSK Investigational Site | Bloomington | Illinois | 61701 | — |
| GSK Investigational Site | Rockford | Illinois | 61107 | — |
| GSK Investigational Site | Elkhart | Indiana | 46515 | — |
| GSK Investigational Site | Evansville | Indiana | 47714 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46250 | — |
| GSK Investigational Site | Newburgh | Indiana | 47630 | — |
| GSK Investigational Site | Lexington | Kentucky | 40504 | — |
| GSK Investigational Site | Louisville | Kentucky | 40213 | — |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | — |
| GSK Investigational Site | Baltimore | Maryland | 21229-5299 | — |
| GSK Investigational Site | Elkridge | Maryland | 21075 | — |
| GSK Investigational Site | Boston | Massachusetts | 02215 | — |
| GSK Investigational Site | Detroit | Michigan | 48202 | — |
| GSK Investigational Site | Portage | Michigan | 49024 | — |
| GSK Investigational Site | Saginaw | Michigan | 48602 | — |
| GSK Investigational Site | Chaska | Minnesota | 55318 | — |
| GSK Investigational Site | Picayune | Mississippi | 39466 | — |
| GSK Investigational Site | Fenton | Missouri | 63026 | — |
| GSK Investigational Site | Manchester | Missouri | 63021 | — |
| GSK Investigational Site | St Louis | Missouri | 63128 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Omaha | Nebraska | 68114 | — |
| GSK Investigational Site | Incline Village | Nevada | 89452 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89146 | — |
| GSK Investigational Site | Elizabeth | New Jersey | 07202 | — |
| GSK Investigational Site | Haddon Heights | New Jersey | 08035 | — |
| GSK Investigational Site | Princeton | New Jersey | 08540 | — |
| GSK Investigational Site | East Syracuse | New York | 13057 | — |
| GSK Investigational Site | New York | New York | 10010 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | Valley Stream | New York | 11580 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28210 | — |
| GSK Investigational Site | Concord | North Carolina | 28025 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27401 | — |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | — |
| GSK Investigational Site | Wilmington | North Carolina | 28412 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45224 | — |
| GSK Investigational Site | Columbus | Ohio | 43215 | — |
| GSK Investigational Site | Dayton | Ohio | 45408 | — |
| GSK Investigational Site | Dayton | Ohio | 45439 | — |
| GSK Investigational Site | Maumee | Ohio | 43537 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| GSK Investigational Site | Eugene | Oregon | 97404 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Oregon City | Oregon | 97045 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Portland | Oregon | 97225 | — |
| GSK Investigational Site | Portland | Oregon | 97232 | — |
| GSK Investigational Site | Bala-Cynwyd | Pennsylvania | 19004 | — |
| GSK Investigational Site | Nazareth | Pennsylvania | 18064 | — |
| GSK Investigational Site | Whitehall | Pennsylvania | 18052 | — |
| GSK Investigational Site | Wyomissing | Pennsylvania | 19610 | — |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | — |
| GSK Investigational Site | Woonsocket | Rhode Island | 02895 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406 | — |
| GSK Investigational Site | Murrells Inlet | South Carolina | 29576 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Arlington | Texas | 76017 | — |
| GSK Investigational Site | Brownwood | Texas | 76801 | — |
| GSK Investigational Site | Colleyville | Texas | 76034 | — |
| GSK Investigational Site | Galveston | Texas | 77555 | — |
| GSK Investigational Site | Houston | Texas | 77054 | — |
| GSK Investigational Site | Houston | Texas | 77074 | — |
| GSK Investigational Site | Lake Jackson | Texas | 77566 | — |
| GSK Investigational Site | San Antonio | Texas | 78205 | — |
| GSK Investigational Site | San Antonio | Texas | 78238 | — |
| GSK Investigational Site | Alexandria | Virginia | 22304 | — |
| GSK Investigational Site | Chesapeake | Virginia | 23322 | — |
| GSK Investigational Site | Christiansburg | Virginia | 24073 | — |
| GSK Investigational Site | Danville | Virginia | 24541 | — |
| GSK Investigational Site | Virginia Beach | Virginia | 23452 | — |
| GSK Investigational Site | Bellingham | Washington | 98226 | — |
| GSK Investigational Site | Edmonds | Washington | 98026 | — |
| GSK Investigational Site | Lacey | Washington | 98516 | — |
| GSK Investigational Site | Spokane | Washington | 99204 | — |
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 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00256932, 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 25, 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 NCT00256932 live on ClinicalTrials.gov.