Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.
Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alvimopan 0.5 mg Twice Daily (BID) | Experimental | 0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening. |
|
| Alvimopan 1 mg Once Daily (QD) | Experimental | Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks. |
|
| Alvimopan 1 mg Twice Daily (BID) | Experimental | Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening. |
|
| Placebo | Placebo Comparator | Placebo was administered orally once in the morning and once in evening. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alvimopan | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reported adverse events, including serious adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Duarte | California | 91010 | United States | ||
| GSK Investigational Site |
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
|
| Fountain Valley |
| California |
| 92708 |
| United States |
| GSK Investigational Site | La Verne | California | 91750 | United States |
| GSK Investigational Site | Sacramento | California | 95819 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | New Port Richey | Florida | 34652 | United States |
| GSK Investigational Site | Tampa | Florida | 33612-9497 | United States |
| GSK Investigational Site | West Des Moines | Iowa | 50265 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01608 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Hendersonville | North Carolina | 28793 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| GSK Investigational Site | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| GSK Investigational Site | Kitchener | Ontario | N2G 1G3 | Canada |
| GSK Investigational Site | Bonaventure | Quebec | G0C 1E0 | Canada |
| GSK Investigational Site | Chandler | Quebec | G0C 1K0 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| GSK Investigational Site | Helsinki | 00029 | Finland |
| GSK Investigational Site | Bordeaux | 33076 | France |
| GSK Investigational Site | Strasbourg | 67000 | France |
| GSK Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| GSK Investigational Site | Villejuif | 94805 | France |
| GSK Investigational Site | Kwun Tong | Hong Kong |
| GSK Investigational Site | Wellington | 6002 | New Zealand |
| GSK Investigational Site | Lahore | 54600 | Pakistan |
| GSK Investigational Site | Lima | Lima Province | Lima 34 | Peru |
| GSK Investigational Site | Bialystok | 15-540 | Poland |
| GSK Investigational Site | Lublin | 20-090 | Poland |
| GSK Investigational Site | Olsztyn | 10-228 | Poland |
| GSK Investigational Site | Otwock | 05-400 | Poland |
| GSK Investigational Site | Poznan | 60-569 | Poland |
| GSK Investigational Site | Lisbon | 1070 | Portugal |
| GSK Investigational Site | Lisbon | 1800 | Portugal |
| GSK Investigational Site | Moscow | 117216 | Russia |
| GSK Investigational Site | Alcorcón | 28922 | Spain |
| GSK Investigational Site | Nottingham | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007410 | Intestinal Diseases |
| D003248 | Constipation |
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C419502 | alvimopan |
Not provided
Not provided
Not provided