Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects



Status:Completed
Conditions:Cancer, Cancer, Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2004
End Date:April 2007

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
15
sites
Tampa, Florida 33612
2134
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Boston, Massachusetts 02115
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
Duarte, California 91010
5
mi
from 91732
Duarte, CA
Click here to add this to my saved trials
Durham, North Carolina 27705
2198
mi
from 91732
Durham, NC
Click here to add this to my saved trials
Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Hendersonville, North Carolina 28739
2010
mi
from 91732
Hendersonville, NC
Click here to add this to my saved trials
La Verne, California 91750
14
mi
from 91732
La Verne, CA
Click here to add this to my saved trials
New Port Richey, Florida 34655
2118
mi
from 91732
New Port Richey, FL
Click here to add this to my saved trials
Sacramento, California 95815
365
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
San Diego, California 92111
99
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
St. Louis, Missouri 63110
1570
mi
from 91732
St. Louis, MO
Click here to add this to my saved trials
Tacoma, Washington 98405
939
mi
from 91732
Tacoma, WA
Click here to add this to my saved trials
West Des Moines, Iowa 50265
1416
mi
from 91732
West Des Moines, IA
Click here to add this to my saved trials
Winnipeg, Manitoba
1521
mi
from 91732
Winnipeg,
Click here to add this to my saved trials
Worcester, Massachusetts 01655
2542
mi
from 91732
Worcester, MA
Click here to add this to my saved trials