Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Cancer, Bowel Dysfunction
About this trial
This is an interventional treatment trial for Cancer focused on measuring opioids, constipation, opioid-induced bowel dysfunction
Eligibility Criteria
Inclusion Criteria: Completed GSK sponsored alvimopan (opioid-induced bowel dysfunction) OBD study for subjects with cancer-related pain, e.g. SB-767905/008. Taking full agonist opioid therapy for cancer related pain. Met entry criteria of OBD in original study and per investigator continues to require therapy for management of OBD. Capable of completing paper questionnaires at the study visits. Exclusion Criteria: Unable to eat or drink. Taking opioids for management of drug addiction. Unable to use only rescue laxatives provided. Inappropriately managed severe constipation that puts subject at risk of complications. Has gastrointestinal (GI) or pelvic disorder known to affect bowel transit. Concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Alvimopan 0.5 mg Twice Daily (BID)
Alvimopan 1 mg Once Daily (QD)
Alvimopan 1 mg Twice Daily (BID)
Placebo
0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening.
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.
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 was administered orally once in the morning and once in evening.