Status:
COMPLETED
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Cancer
Bowel Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00135577
Start Date
September 1 2004
End Date
April 1 2007
Last Update
September 2 2015
Active Locations (40)
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1
GSK Investigational Site
Duarte, California, United States, 91010
2
GSK Investigational Site
Fountain Valley, California, United States, 92708
3
GSK Investigational Site
La Verne, California, United States, 91750
4
GSK Investigational Site
Sacramento, California, United States, 95819