Constipation Clinical Trial
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
| Verified date | September 2009 |
| Source | Cubist Pharmaceuticals LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 485 |
| Est. completion date | |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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). - Willing to report daily bowel symptoms. 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. - HIV-infected, has active hepatitis, or has ever been infected with hepatitis C. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | GSK Investigational Site | Bedford Park | South Australia |
| Australia | GSK Investigational Site | Box Hill | Victoria |
| Australia | GSK Investigational Site | Broadmeadow | New South Wales |
| Australia | GSK Investigational Site | Carina Heights | Queensland |
| Australia | GSK Investigational Site | Carlton | Victoria |
| Australia | GSK Investigational Site | Fremantle | Western Australia |
| Australia | GSK Investigational Site | Kippa Ring | Queensland |
| Australia | GSK Investigational Site | Nedlands | Western Australia |
| Australia | GSK Investigational Site | Newcastle | New South Wales |
| Australia | GSK Investigational Site | Port Lincoln | South Australia |
| Australia | GSK Investigational Site | St Leonards | New South Wales |
| Australia | GSK Investigational Site | Toorak Gardens | South Australia |
| Canada | GSK Investigational Site | Bonaventure | Quebec |
| Canada | GSK Investigational Site | Coquitlam | British Columbia |
| Canada | GSK Investigational Site | Mississauga | Ontario |
| Canada | GSK Investigational Site | Moncton | New Brunswick |
| Canada | GSK Investigational Site | North Bay | Ontario |
| Canada | GSK Investigational Site | North York | Ontario |
| Canada | GSK Investigational Site | Saint Romuald | Quebec |
| Canada | GSK Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | GSK Investigational Site | Sudbury | Ontario |
| Canada | GSK Investigational Site | Trois-Rivieres | Quebec |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| France | GSK Investigational Site | Boulogne | |
| France | GSK Investigational Site | Grenoble | |
| France | GSK Investigational Site | Montpellier Cedex 5 | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris Cedex 4 | |
| Hungary | GSK Investigational Site | Budapest | |
| Hungary | GSK Investigational Site | Budapest | |
| Hungary | GSK Investigational Site | Csongrád | |
| Hungary | GSK Investigational Site | Heves | |
| Netherlands | GSK Investigational Site | Alkmaar | |
| Netherlands | GSK Investigational Site | Breda | |
| Netherlands | GSK Investigational Site | Roosendaal | |
| Netherlands | GSK Investigational Site | Rotterdam | |
| Netherlands | GSK Investigational Site | Utrecht | |
| New Zealand | GSK Investigational Site | Christchurch | |
| New Zealand | GSK Investigational Site | Hamilton | |
| New Zealand | GSK Investigational Site | Tauranga | |
| Norway | GSK Investigational Site | Oslo | |
| Norway | GSK Investigational Site | Oslo | |
| Norway | GSK Investigational Site | Paradis | |
| Norway | GSK Investigational Site | Rådahl | |
| Norway | GSK Investigational Site | Skien | |
| South Africa | GSK Investigational Site | Athlone, Cape Town | |
| South Africa | GSK Investigational Site | Erasmuskloof, Pretoria | |
| South Africa | GSK Investigational Site | Fourways, Johannesburg | |
| South Africa | GSK Investigational Site | Kempton Park | |
| South Africa | GSK Investigational Site | Kenilworth, Cape Town | |
| South Africa | GSK Investigational Site | Lynnwood, Pretoria | |
| South Africa | GSK Investigational Site | Tygervalley | |
| South Africa | GSK Investigational Site | Westridge, Mitchells Plain | |
| Spain | GSK Investigational Site | Alcorcon | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | El Ferrol | |
| Spain | GSK Investigational Site | Granada | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Santander | |
| Spain | GSK Investigational Site | Valencia | |
| Sweden | GSK Investigational Site | Jönköping | |
| Sweden | GSK Investigational Site | Karlstad | |
| Sweden | GSK Investigational Site | Linköping | |
| Sweden | GSK Investigational Site | Stockholm | |
| Switzerland | GSK Investigational Site | Bern | |
| Switzerland | GSK Investigational Site | Nottwil | |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Bakersfield | California |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Blackwood | New Jersey |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Brockton | Massachusetts |
| United States | GSK Investigational Site | Centerville | Ohio |
| United States | GSK Investigational Site | Charleston | West Virginia |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chiefland | Florida |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Corpus Christi | Texas |
| United States | GSK Investigational Site | Cranston | Rhode Island |
| United States | GSK Investigational Site | Cumming | Georgia |
| United States | GSK Investigational Site | Dayton | Ohio |
| United States | GSK Investigational Site | Deerfield Beach | Florida |
| United States | GSK Investigational Site | Destin | Florida |
| United States | GSK Investigational Site | Dover | New Hampshire |
| United States | GSK Investigational Site | Egg Harbor Township | New Jersey |
| United States | GSK Investigational Site | Eugene | Oregon |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Fort Myers | Florida |
| United States | GSK Investigational Site | Galveston | Texas |
| United States | GSK Investigational Site | Greensboro | North Carolina |
| United States | GSK Investigational Site | Greer | South Carolina |
| United States | GSK Investigational Site | Hickory | North Carolina |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Huntsville | Alabama |
| United States | GSK Investigational Site | Independence | Missouri |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Kingsport | Tennessee |
| United States | GSK Investigational Site | La Crosse | Wisconsin |
| United States | GSK Investigational Site | Largo | Florida |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Levittown | Pennsylvania |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Libertyville | Illinois |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Gatos | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Margate | Florida |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Meridian | Idaho |
| United States | GSK Investigational Site | Mesa | Arizona |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Mineola | New York |
| United States | GSK Investigational Site | Missoula | Montana |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | New Tazewell | Tennessee |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | Northport | Alabama |
| United States | GSK Investigational Site | Northridge | California |
| United States | GSK Investigational Site | Oak Forest | Illinois |
| United States | GSK Investigational Site | Oakbrook Terrace | Illinois |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Olive Branch | Mississippi |
| United States | GSK Investigational Site | Orange | California |
| United States | GSK Investigational Site | Ormond Beach | Florida |
| United States | GSK Investigational Site | Palm Springs | California |
| United States | GSK Investigational Site | Pasadena | California |
| United States | GSK Investigational Site | Pasadena | Maryland |
| United States | GSK Investigational Site | Perrysburg | Ohio |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Portage | Michigan |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Reading | Pennsylvania |
| United States | GSK Investigational Site | Richardson | Texas |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Rochester | New York |
| United States | GSK Investigational Site | Rockville | Maryland |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Salem | Oregon |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Rafael | California |
| United States | GSK Investigational Site | Santa Ana | California |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | St. Cloud | Florida |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Stamford | Connecticut |
| United States | GSK Investigational Site | Stockbridge | Georgia |
| United States | GSK Investigational Site | Sunset | Louisiana |
| United States | GSK Investigational Site | Tacoma | Washington |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Tempe | Arizona |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | Waterbury | Connecticut |
| United States | GSK Investigational Site | Waterford | Michigan |
| United States | GSK Investigational Site | Wellesley Hills | Massachusetts |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| United States | GSK Investigational Site | Winterhaven | Florida |
| United States | GSK Investigational Site | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Cubist Pharmaceuticals LLC | GlaxoSmithKline |
United States, Australia, Canada, France, Hungary, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland,
Irving G, Pénzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in pati — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To compare alvimopan with placebo for efficacy in the treatment of OBD | |||
| Secondary | Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data) |
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