A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer, Bowel Dysfunction
Both
Cancer, Bowel Dysfunction
Trial Information
A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Incidence of reported adverse events, including serious adverse events
Principal Investigator
GSK Clinical Trials, MD
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
ABD101684
NCT ID:
NCT00135577
Start Date:
September 2004
Completion Date:
Related Keywords:
- Cancer
- Bowel Dysfunction
- opioids
- constipation
- opioid-induced bowel dysfunction
- Intestinal Diseases
- Gastrointestinal Diseases
Name | Location |
|---|---|
| GSK Investigational Site | Bakersfield, California 93309 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Springfield, Massachusetts 01107 |
| GSK Investigational Site | St. Louis, Missouri 63141 |
| GSK Investigational Site | Raleigh, North Carolina 27609 |
| GSK Investigational Site | Bettendorf, Iowa 52722 |
| GSK Investigational Site | Seattle, Washington 98133 |
